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 PCR Kit
ABP-PP-BD02100	Allele Biotech	100 RXNS	Ask for price

Allele-In-One Human Blood Direct PCR Kit
ABP-PP-BD02500	Allele Biotech	500 RXNS	Ask for price

Allele-In-One Mouse Tail Direct Lysis Buffer
ABP-PP-MT01100	Allele Biotech	100 RXNS	Ask for price

Allele-In-One Mouse Tail Direct Lysis Buffer
ABP-PP-MT01500	Allele Biotech	500 RXNS	Ask for price

Allele-In-One Mouse Tail Direct PCR Kit
ABP-PP-MT02100	Allele Biotech	100 RXNS	Ask for price

Allele-In-One Mouse Tail Direct PCR Kit
ABP-PP-MT02500	Allele Biotech	500 RXNS	Ask for price

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
201-12-1892	SunredBio	96 tests	EUR 440
Description: A quantitative ELISA kit for measuring Human in samples from biological fluids.

Oligonucleotide Binding Fold Containing 1 Protein
20-abx262451	Abbexa	EUR 328.00 EUR 6397.00 EUR 230.00	10 ug 1 mg 2 µg

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

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

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

ELISA kit for Human Nonmethylated oligonucleotide (NON)
KTE62600-48T	Abbkine	48T	EUR 354
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
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
Description: Quantitative sandwich ELISA for measuring Human Nonmethylated oligonucleotide (NON) in samples from cell culture supernatants, serum, whole blood, plasma and other biological fluids.

Testis-specific kinase substrate (TSKS) polyclonal antibody
ABP-PAB-10265	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease (SENP1) polyclonal antibody
ABP-PAB-11087	Allele Biotech	100 ug	Ask for price

Ubiquitin specific protease 6 (USP6) polyclonal antibody
ABP-PAB-11313	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 1 (SENP1) polyclonal antibody
ABP-PAB-10330	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 1 (SENP1) polyclonal antibody
ABP-PAB-10331	Allele Biotech	100 ug	Ask for price

SUMO1/sentrin specific protease 6 (SENP6) polyclonal antibody
ABP-PAB-10338	Allele Biotech	100 ug	Ask for price

SUMO1/sentrin specific protease 6 (SENP6) polyclonal antibody
ABP-PAB-10339	Allele Biotech	100 ug	Ask for price

Brain-specific angiogenesis inhibitor 1 (BAI1) polyclonal antibody
ABP-PAB-10421	Allele Biotech	100 ug	Ask for price

Brain-specific angiogenesis inhibitor 2 (BAI2) polyclonal antibody
ABP-PAB-10422	Allele Biotech	100 ug	Ask for price

Brain-specific angiogenesis inhibitor 3 (BAI3) polyclonal antibody
ABP-PAB-10423	Allele Biotech	100 ug	Ask for price

Kallikrein 3 (KLK3, Prostate Specific Antigen, PSA) polyclonal antibody
ABP-PAB-10235	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 5 (SENP5, MGC27076) polyclonal antibody
ABP-PAB-10336	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 5 (SENP5, MGC27076) polyclonal antibody
ABP-PAB-10337	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 2, N-terminus (SENP2) polyclonal antibody
ABP-PAB-10332	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 2, C-terminus (SENP2) polyclonal antibody
ABP-PAB-10333	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 3, N-terminus (SENP3) polyclonal antibody
ABP-PAB-10334	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 3, C-terminus (SENP3) polyclonal antibody
ABP-PAB-10335	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 7, N-terminus (SENP7) polyclonal antibody
ABP-PAB-10340	Allele Biotech	100 ug	Ask for price

Sentrin/SUMO-specific protease 7, C-terminus (SENP7) polyclonal antibody
ABP-PAB-10341	Allele Biotech	100 ug	Ask for price

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.

Human Suppressor of G2 allele of SKP1 homolog, SUGT1 ELISA KIT
ELI-52628h	Lifescience Market	96 Tests	EUR 824

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
ELI-18768m	Lifescience Market	96 Tests	EUR 865

Mouse Ig gamma- 2A chain C region, A allele, Ighg ELISA KIT
ELI-47186m	Lifescience Market	96 Tests	EUR 865

REDD1 Specific (REDD1 specific) Antibody
abx237228-100ug	Abbexa	100 ug	EUR 509

TDRKH Specific (TDRKH specific) Antibody
abx238580-100ug	Abbexa	100 ug	EUR 509

Human TDRKH specific (TDRKH specific) ELISA Kit
abx259882-96tests	Abbexa	96 tests	EUR 911

Neuron Specific Peptide
5-01606	CHI Scientific	4 x 1mg	Ask for price

ACADL-Specific Antibody
abx230064-100ug	Abbexa	100 ug	EUR 481

ADAM17-Specific Antibody
abx230139-100ug	Abbexa	100 ug	EUR 481

ADRA1A-Specific Antibody
abx230177-100ug	Abbexa	100 ug	EUR 481

ADRA2B-Specific Antibody
abx230179-100ug	Abbexa	100 ug	EUR 509

AFF1-Specific Antibody
abx230195-100ug	Abbexa	100 ug	EUR 481

AKAP11-Specific Antibody
abx230251-100ug	Abbexa	100 ug	EUR 481

AMPD1-Specific Antibody
abx230370-100ug	Abbexa	100 ug	EUR 509

ARF5-Specific Antibody
abx230534-100ug	Abbexa	100 ug	EUR 481

ARF6-Specific Antibody
abx230535-100ug	Abbexa	100 ug	EUR 481

ARHGEF9-Specific Antibody
abx230565-100ug	Abbexa	100 ug	EUR 481

ARSK-Specific Antibody
abx230613-100ug	Abbexa	100 ug	EUR 481

ATF2-Specific Antibody
abx230661-100ug	Abbexa	100 ug	EUR 481

ATP1A1-Specific Antibody
abx230692-100ug	Abbexa	100 ug	EUR 509

ATP1A2-Specific Antibody
abx230694-100ug	Abbexa	100 ug	EUR 509

ATP5G2-Specific Antibody
abx230708-100ug	Abbexa	100 ug	EUR 481

BAG1S-specific Antibody
abx230788-100ug	Abbexa	100 ug	EUR 509

BAI2-Specific Antibody
abx230791-100ug	Abbexa	100 ug	EUR 481

BAI3-Specific Antibody
abx230792-100ug	Abbexa	100 ug	EUR 481

Barkor-Specific Antibody
abx230806-100ug	Abbexa	100 ug	EUR 481

BRN2-Specific Antibody
abx230963-100ug	Abbexa	100 ug	EUR 481

BTF3L3-Specific Antibody
abx230976-100ug	Abbexa	100 ug	EUR 481

CAPG-Specific Antibody
abx231249-100ug	Abbexa	100 ug	EUR 481

Catalase-Specific Antibody
abx231302-100ug	Abbexa	100 ug	EUR 481

CCKAR-specific Antibody
abx231377-100ug	Abbexa	100 ug	EUR 481

CCKBR-specific Antibody
abx231378-100ug	Abbexa	100 ug	EUR 481

CCR2-specific Antibody
abx231390-100ug	Abbexa	100 ug	EUR 481

CCT6A-Specific Antibody
abx231401-100ug	Abbexa	100 ug	EUR 481

CD68-Specific Antibody
abx231493-100ug	Abbexa	100 ug	EUR 509

CDH10-specific Antibody
abx231546-100ug	Abbexa	100 ug	EUR 481

CDK1-Specific Antibody
abx231552-100ug	Abbexa	100 ug	EUR 481

CEACAM3-Specific Antibody
abx231578-100ug	Abbexa	100 ug	EUR 481

CEP350-Specific Antibody
abx231603-100ug	Abbexa	100 ug	EUR 481

CES7-Specific Antibody
abx231618-100ug	Abbexa	100 ug	EUR 481

CHST13-Specific Antibody
abx231693-100ug	Abbexa	100 ug	EUR 509

CISD2-Specific Antibody
abx231719-100ug	Abbexa	100 ug	EUR 481

CPNE9-Specific Antibody
abx231932-100ug	Abbexa	100 ug	EUR 481

CPT1B-specific Antibody
abx231944-100ug	Abbexa	100 ug	EUR 509

CPT1C-specific Antibody
abx231946-100ug	Abbexa	100 ug	EUR 481

CRLS1-Specific Antibody
abx231983-100ug	Abbexa	100 ug	EUR 509

CST2-Specific Antibody
abx232033-100ug	Abbexa	100 ug	EUR 481

MCL1L-specific Antibody
abx235054-100ug	Abbexa	100 ug	EUR 481

MDM1-Specific Antibody
abx235076-100ug	Abbexa	100 ug	EUR 509

MEF2C-Specific Antibody
abx235107-100ug	Abbexa	100 ug	EUR 481

MYH10-Specific Antibody
abx235472-100ug	Abbexa	100 ug	EUR 481

MYH4-Specific Antibody
abx235476-100ug	Abbexa	100 ug	EUR 509

MYH7-specific Antibody
abx235478-100ug	Abbexa	100 ug	EUR 509

MYOM1-Specific Antibody
abx235516-100ug	Abbexa	100 ug	EUR 481

MYPN-Specific Antibody
abx235525-100ug	Abbexa	100 ug	EUR 551

MYSM1-Specific Antibody
abx235527-100ug	Abbexa	100 ug	EUR 551

NARFL-Specific Antibody
abx235553-100ug	Abbexa	100 ug	EUR 509

NEB-Specific Antibody
abx235638-100ug	Abbexa	100 ug	EUR 509

Neogenin-Specific Antibody
abx235662-100ug	Abbexa	100 ug	EUR 481

neurturin-Specific Antibody
abx235683-100ug	Abbexa	100 ug	EUR 551

NFIX-Specific Antibody
abx235701-100ug	Abbexa	100 ug	EUR 509

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.