Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial.

One potential stressor that can affect preimplantation and postimplantation embryonic growth after in vitro fertilisation (IVF) is the pH of the human embryo culture medium, but no evidence exists to indicate which pH level is optimal for IVF.

Based on anecdotal evidence or mouse models, culture media manufacturers recommend a pH range of 7.2 to 7.4, and IVF laboratories routinely use a pH range of 7.25 to 7.3. Given the lack of randomised trials evaluating the effect of pH on live birth rate after IVF, this trial examines the effect of three different pH levels on the live birth rate.

This multicentre randomised trial will involve centres specialised in IVF in Egypt. Eligible couples for intracytoplasmic sperm injection (ICSI) will be randomised for embryo culture at pH 7.2, 7.3 or 7.4. The study is designed to detect 10 percentage points difference in live birth rate between the best and worst performing media with 93% power at a 1% significance level.

The primary outcome is the rate of live birth (delivery of one or more viable infants beyond the 20th week of gestation) after ICSI. Secondary clinical outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, preterm births, birth weight, stillbirth, congenital malformation and cumulative live birth (within 1 year from randomisation).

Allele-In-One Human Blood Direct Lysis Buffer
ABP-PP-BD01500	Allele Biotech	500 RXNS	Ask for price
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Allele-In-One Human Blood Direct PCR Kit
ABP-PP-BD02100	Allele Biotech	100 RXNS	Ask for price
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ABP-PP-BD02500	Allele Biotech	500 RXNS	Ask for price
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Allele-In-One Mouse Tail Direct Lysis Buffer
ABP-PP-MT01100	Allele Biotech	100 RXNS	Ask for price
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Allele-In-One Mouse Tail Direct Lysis Buffer
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Human nonmethylated oligonucleotide,NON ELISA Kit
201-12-1892	SunredBio	96 tests	EUR 440
This nonmethylated oligonucleotide ELISA kit is validated to work with samples from whole blood, serum, plasma and cell culture supernatant.
Description: A quantitative ELISA kit for measuring Human in samples from biological fluids.

Human nonmethylated oligonucleotide,NON ELISA Kit
CN-04463H1	ChemNorm	96T	EUR 452

Human nonmethylated oligonucleotide,NON ELISA Kit
CN-04463H2	ChemNorm	48T	EUR 302

Oligonucleotide Binding Fold Containing 1 Protein
20-abx262451	Abbexa	EUR 328.00 EUR 6397.00 EUR 230.00	10 ug 1 mg 2 µg
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Human nonmethylated oligonucleotide(NON)ELISA Kit
GA-E1908HM-48T	GenAsia Biotech	48T	EUR 289

Human nonmethylated oligonucleotide(NON)ELISA Kit
GA-E1908HM-96T	GenAsia Biotech	96T	EUR 466

Human nonmethylated oligonucleotide(NON)ELISA Kit
QY-E03624	Qayee Biotechnology	96T	EUR 413

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Sentrin/SUMO-specific protease (SENP1) polyclonal antibody
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ELISA kit for Human Nonmethylated oligonucleotide (NON)
KTE62600-48T	Abbkine	48T	EUR 354
Oligonucleotides are short DNA or RNA molecules, oligomers, that have a wide range of applications in genetic testing, research, and forensics. Commonly made in the laboratory by solid-phase chemical synthesis, these small bits of nucleic acids can b Show more
Description: Quantitative sandwich ELISA for measuring Human Nonmethylated oligonucleotide (NON) in samples from cell culture supernatants, serum, whole blood, plasma and other biological fluids.

ELISA kit for Human Nonmethylated oligonucleotide (NON)
KTE62600-5platesof96wells	Abbkine	5 plates of 96 wells	EUR 2252
Oligonucleotides are short DNA or RNA molecules, oligomers, that have a wide range of applications in genetic testing, research, and forensics. Commonly made in the laboratory by solid-phase chemical synthesis, these small bits of nucleic acids can b Show more
Description: Quantitative sandwich ELISA for measuring Human Nonmethylated oligonucleotide (NON) in samples from cell culture supernatants, serum, whole blood, plasma and other biological fluids.

ELISA kit for Human Nonmethylated oligonucleotide (NON)
KTE62600-96T	Abbkine	96T	EUR 572
Oligonucleotides are short DNA or RNA molecules, oligomers, that have a wide range of applications in genetic testing, research, and forensics. Commonly made in the laboratory by solid-phase chemical synthesis, these small bits of nucleic acids can b Show more
Description: Quantitative sandwich ELISA for measuring Human Nonmethylated oligonucleotide (NON) in samples from cell culture supernatants, serum, whole blood, plasma and other biological fluids.

Sentrin/SUMO-specific protease 1 (SENP1) polyclonal antibody
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Sentrin/SUMO-specific protease 1 (SENP1) polyclonal antibody
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SUMO1/sentrin specific protease 6 (SENP6) polyclonal antibody
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SUMO1/sentrin specific protease 6 (SENP6) polyclonal antibody
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Sentrin/SUMO-specific protease 5 (SENP5, MGC27076) polyclonal antibody
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Sentrin/SUMO-specific protease 5 (SENP5, MGC27076) polyclonal antibody
ABP-PAB-10337	Allele Biotech	100 ug	Ask for price
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Sentrin/SUMO-specific protease 2, N-terminus (SENP2) polyclonal antibody
ABP-PAB-10332	Allele Biotech	100 ug	Ask for price
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OBFC1 Oligonucleotide Binding Fold Containing 1 Human Recombinant Protein
PROTQ9H668	BosterBio	Regular: 10ug	EUR 317
Description: OBFC1 Human Recombinant produced in E. coli is. a single polypeptide chain containing 391 amino acids (1-368) and having a molecular mass of 44.5kDa. OBFC1 is fused to a 23 amino acid His-tag at N-terminus & purified by proprietary chromatographic techniques.

Bovine Suppressor of G2 allele of SKP1 homolog, SUGT1 ELISA KIT
ELI-13668b	Lifescience Market	96 Tests	EUR 928

Mouse Suppressor of G2 allele of SKP1 homolog, Sugt1 ELISA KIT
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ELI-52628h	Lifescience Market	96 Tests	EUR 824

Mouse Ig gamma- 2A chain C region, A allele, Ighg ELISA KIT
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TDRKH Specific (TDRKH specific) Antibody
abx238580-100ug	Abbexa	100 ug	EUR 509
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REDD1 Specific (REDD1 specific) Antibody
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Human TDRKH specific (TDRKH specific) ELISA Kit
abx259882-96tests	Abbexa	96 tests	EUR 911
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Neuron Specific Peptide
5-01606	CHI Scientific	4 x 1mg	Ask for price

PFKFB3-Specific Antibody
DF12016	Affbiotech	200ul	EUR 304
Description: PFKFB3-Specific antibody detects endogenous levels of PFKFB3-Specific.

PLOD2-Specific Antibody
DF12018	Affbiotech	200ul	EUR 304
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FcRn-Specific Antibody
DF12607	Affbiotech	200ul	EUR 304
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NEB-Specific Antibody
DF12667	Affbiotech	200ul	EUR 304
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DF12754	Affbiotech	200ul	EUR 304
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DLL1-Specific Antibody
DF12945	Affbiotech	200ul	EUR 304
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LC3C-Specific Antibody
DF13125	Affbiotech	200ul	EUR 304
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MYH10-Specific Antibody
DF13164	Affbiotech	200ul	EUR 304
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MYOM1-Specific Antibody
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Neogenin-Specific Antibody
DF13183	Affbiotech	200ul	EUR 304
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MYH7-specific Antibody
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CPT1C-specific Antibody
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Description: CPT1C-specific antibody detects endogenous levels of CPT1C-specific.

MYH4-Specific Antibody
DF12165	Affbiotech	200ul	EUR 304
Description: MYH4-Specific antibody detects endogenous levels of MYH4-Specific.

CRLS1-Specific Antibody
DF12373	Affbiotech	200ul	EUR 304
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PACS2-Specific Antibody
DF12441	Affbiotech	200ul	EUR 304
Description: PACS2-Specific antibody detects endogenous levels of PACS2-Specific.

SEC61B-Specific Antibody
abx237691-100ug	Abbexa	100 ug	EUR 509
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SENP5-Specific Antibody
abx237714-100ug	Abbexa	100 ug	EUR 509
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SERINC2-Specific Antibody
abx237736-100ug	Abbexa	100 ug	EUR 509
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SIRT2-Specific Antibody
abx237880-100ug	Abbexa	100 ug	EUR 509
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SLC12A5-Specific Antibody
abx237908-100ug	Abbexa	100 ug	EUR 509
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SLC25A6-Specific Antibody
abx237947-100ug	Abbexa	100 ug	EUR 509
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SLIT2-Specific Antibody
abx237981-100ug	Abbexa	100 ug	EUR 509
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SMYD1-Specific Antibody
abx238047-100ug	Abbexa	100 ug	EUR 509
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Somatostatin-Specific Antibody
abx238109-100ug	Abbexa	100 ug	EUR 509
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SPAG4-Specific Antibody
abx238142-100ug	Abbexa	100 ug	EUR 509
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SPIN1-Specific Antibody
abx238178-100ug	Abbexa	100 ug	EUR 551
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SPTBN1-Specific Antibody
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SRGAP3-Specific Antibody
abx238227-100ug	Abbexa	100 ug	EUR 509
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ST8SIA2-Specific Antibody
abx238276-100ug	Abbexa	100 ug	EUR 509
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STEAP2-Specific Antibody
abx238317-100ug	Abbexa	100 ug	EUR 509
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SURVIVIN-Specific Antibody
abx238403-100ug	Abbexa	100 ug	EUR 481
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SYN1-Specific Antibody
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TAF1-Specific Antibody
abx238484-100ug	Abbexa	100 ug	EUR 551
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TGFBR3-Specific Antibody
abx238645-100ug	Abbexa	100 ug	EUR 551
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TINAG-Specific Antibody
abx238712-100ug	Abbexa	100 ug	EUR 551
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TMF1-Specific Antibody
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TOP2A-Specific Antibody
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Tuberin-Specific Antibody
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TWIST1-specific Antibody
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UBASH3A-Specific Antibody
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UBC9-Specific Antibody
abx239159-100ug	Abbexa	100 ug	EUR 509
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UBE2D1-Specific Antibody
abx239167-100ug	Abbexa	100 ug	EUR 509
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UBN1-Specific Antibody
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UNC5C-Specific Antibody
abx239263-100ug	Abbexa	100 ug	EUR 509
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UNC5D-Specific Antibody
abx239264-100ug	Abbexa	100 ug	EUR 551
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URB1-Specific Antibody
abx239286-100ug	Abbexa	100 ug	EUR 551
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WASF4-Specific Antibody
abx239469-100ug	Abbexa	100 ug	EUR 551
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YES1-Specific Antibody
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ZIC4-Specific Antibody
abx239637-100ug	Abbexa	100 ug	EUR 551
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abx239718-100ug	Abbexa	100 ug	EUR 551
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ZNRF2-Specific Antibody
abx239746-100ug	Abbexa	100 ug	EUR 509
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Embryo development outcomes include fertilisation, blastocyst formation and quality, and embryo cryopreservation and utilisation. The study was reviewed and approved by the Ethics Review Boards of the participating centres. Eligible women will sign a written informed consent before enrolment.

This study has an independent data monitoring and safety committee comprised international experts in trial design and in vitro culture. No plan exists to disseminate results to participants or health communities, except for the independent monitoring and safety committee of the trial.