CompletedNot Applicable

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

France429 participantsStarted 2020-10-14

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Couples whose woman is 18 to 40 years old and man is 18 to 60 at the time of inclusion. * 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. * Fitting the inclusion criteria for IVF according the the French law. Exclusion Criteria: * 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) infected with HIV, HCV or HBV in the year before the inclusion * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Live birth delivery rate

Timeframe: month 9

Trial details

NCT IDNCT04456478

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-19

View on ClinicalTrials.gov More Embryo Growth Disorder trials