Impact of PH Values of the Embryo Culture Medium on Success of in Vitro Fertilization (IVF)

NCT04456478 | Completed

• 2 other identifiers: RC31/19/05032020-A00221-38
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to compare, through a multicentric randomized trial, the impact of two pH values in the embryo culture medium on the clinical results of In Vitro Fertilization (IVF) process and especially the impact on live birth delivery rate.

Conditions

Embryo Growth Disorder; Humans; Pregnancy

Keywords

pH; embryo culture; In Vitro Fertilization; live birth rate; randomized trial

Outcome Measures

Primary Outcomes (1)

• Live birth delivery rate

  Number of deliveries that resulted in at least one live birth (gestational age ≥ 22 weeks) / Number of oocyte retrievals

  month 9

Secondary Outcomes (9)

• Fertilization rate

  day 1

• Cleavage rate

  day 2

• Percentage of top embryos

  day 3

• Embryo freezing rate

  day 6

• Implantation rate

  week 5

Study Arms (2)

pH 7.38 ± 0.02

ACTIVE COMPARATOR

IVF-ICSI will be performed according to the usual procedure and the day of the oocyte puncture, the embryologist will proceed to the culture of the oocytes and embryos in the culture medium with a pH at 7.38 ± 0.02

Procedure: pH at 7.38 ± 0.02

pH 7.22 ± 0.02

EXPERIMENTAL

IVF-ICSI will be performed according to the usual procedure and the day of the oocyte puncture, the embryologist will proceed to the culture of the oocytes and embryos in the culture medium with a pH at 7.22 ± 0.02

Procedure: pH at 7.22 ± 0.02

Interventions

pH at 7.38 ± 0.02 PROCEDURE

In the 3 centers of the study, IVF-ICSI will be performed according to the usual procedure: ovarian stimulation, oocyte retrieval, sperm microinjection by ICSI, embryo culture in Global® Total HSA medium, embryo selection and transfer at day 3. The day of the oocyte puncture, the embryologist will proceed to the 1: 1 randomization: culture of the embryos in a medium with a pH at 7.38 ± 0.02. We have chosen to study specifically the early stages of fertilization and embryo development (until day 3), stages for which extracellular pH control is more critical because the intracellular pH regulatory mechanisms are somewhat limited and could be exceeded.

pH 7.38 ± 0.02

pH at 7.22 ± 0.02 PROCEDURE

In the 3 centers of the study, IVF-ICSI will be performed according to the usual procedure: ovarian stimulation, oocyte retrieval, sperm microinjection by ICSI, embryo culture in Global® Total HSA medium, embryo selection and transfer at day 3. The day of the oocyte puncture, the embryologist will proceed to the 1: 1 randomization: culture of the embryos in a medium with a pH at 7.22 ± 0.02. We have chosen to study specifically the early stages of fertilization and embryo development (until day 3), stages for which extracellular pH control is more critical because the intracellular pH regulatory mechanisms are somewhat limited and could be exceeded.

pH 7.22 ± 0.02

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Couples whose woman is 18 to 40 years old and man is 18 to 60 at the time of inclusion because the study concerns in vitro fertilization
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile couple with a medical indication of IVF-ICSI according to criteria applied in each center.
• First or second ICSI attempt with fresh embryo transfer.
• Signature of informed consent by both partners of the couple
• Affiliation to a social security scheme or equivalent for both partners of the couple.

You may not qualify if:

• Use of spermatozoa extracted by testicular biopsy.
• Freeze-al strategy (without fresh embryo transfer) decided before embryo culture
• Absence of mature oocyte (metaphase II) at the day of the puncture
• Uterine pathology affecting implantation (uterine malformation, diffuse adenomyosis ...)
• One of the two partners (or both) is (are) in safeguarding justice, under guardianship or trusteeship.
• Couple having already participated once in the study.
• Couple enrolled in another interventional clinical study

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (3)

CHU de BORDEAUX

Bordeaux, France

Location

Centre AMP BIOPYRENEES

Pau, France

Location

CHU de TOULOUSE

Toulouse, France

Location

Study Officials

• Nicolas GATIMEL, ph

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric randomized blinded trial

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: October 14, 2020
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

FR (3)