Triple-arm pH Comparison

NCT02896777 | Completed DMC

• 1 other identifier: pH Study
• Study Type: interventional
• Target: 2,273
• Locations: 1 country
• Sites: 6

Brief Summary

The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos.

Conditions

In Vitro Fertilisation Outcome

Keywords

pH; IVF; live birth rate

Outcome Measures

Primary Outcomes (1)

• live-birth rate

  delivery of one or more viable infants \> 20 weeks of gestation

  > 20 weeks of gestation

Secondary Outcomes (20)

• Biochemical pregnancy rate

  within 7 weeks of gestation

• Clinical pregnancy rate

  ≥ 7 weeks of gestation

• Ongoing pregnancy rate

  within 24 weeks of pregnancy

• Miscarriage rate

  within 42 weeks of pregnancy

• Term Live birth rate

  ≥ 37 weeks of gestation

Study Arms (3)

Transfer embryos from 7.20±0.02 pH

EXPERIMENTAL

In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.2±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI.

Other: Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6

Transfer embryos from 7.3±0.02 pH

EXPERIMENTAL

In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.3±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI.

Other: Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6

Transfer embryo from 7.4±0.02

EXPERIMENTAL

In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.4±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI.

Other: Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6

Interventions

Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6 OTHER

Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02.

Transfer embryos from 7.20±0.02 pH

Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6 OTHER

Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02.

Transfer embryos from 7.3±0.02 pH

Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6 OTHER

Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6

Transfer embryo from 7.4±0.02

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women age of ≥ 18 to ≤ 40
• BMI of ≤ 35 (After approval of the DMC on 19 Feb 2021 and the IRB thereafter, BMI is changed from ≤31 to ≤35 based on clinician request. DMC).
• Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination)
• PCOS
• Women who have ≥ 1 year of primary or secondary infertility
• Tubal factor (unilateral, bilateral obstruction or salpingectomy)
• Normal semen parameters
• Male factor: oligoasthenozoospermia or obstructive azoospermia
• Women who are undergoing their first IVF or ICSI cycle or second IVF Cycle with previous successful attempt
• Women who will undergo only fresh embryo transfer
• Women who have normal endometrial thickness (\> 7 mm) and echo-pattern at the time of hCG trigger
• Women who have normal transvaginal ultrasound during the follicular phase (defined as no intra cavity pathology; e.g. submucousal myomas, polyps or septa)

You may not qualify if:

• Women who had unilateral oophorectomy
• Women who had uterine pathology or abnormality
• Women or their husbands who had abnormal karyotyping
• Women with history of recurrent abortions or repeated implantation failures
• Women who had uncontrolled diabetes
• Women with diagnosed or undiagnosed liver or renal disease
• Women who had a history of severe ovarian hyperstimulation
• Women who had history of malignancy or borderline pathology
• Women who will refuse to participate in the study
• Women with endometriosis
• Patient undergoing PGS or PGD
• Severe male factor and non-obstructive azoospermia.

Sponsors & Collaborators

• Ibn Sina Hospital: lead
• Egyptian IVF Center: collaborator
• Banon IVF Center Assiut, Egypt: collaborator

Study Sites (6)

Qena Fertility Center

Qina, Qena Governorate, 123456, Egypt

Location

Royal Centre

Al Mansurah, 123456, Egypt

Location

Banon Assiut

Asyut, Egypt

Location

Egyptian IVF-ET Center

Cairo, Egypt

Location

Amshaj

Sohag, 12345, Egypt

Location

IbnSina IVF Center

Sohag, Egypt

Location

Related Publications (1)

• Fawzy M, Emad M, Wilkinson J, Mansour R, Mahran A, Fetih A, Abdelrahman M, AbdelGhafar H. Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial. BMJ Open. 2020 Feb 4;10(2):e034194. doi: 10.1136/bmjopen-2019-034194.

  PMID: 32024790 DERIVED

Study Officials

• Mohamed Fawzy

  Ibnsina Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IVF Lab Director

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 12, 2016
• Study Start: June 13, 2020
• Primary Completion: April 27, 2023
• Study Completion: August 11, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (6)