CompletedPhase 3

Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

Belgium87 participantsStarted 2021-04-02

Plain-language summary

The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as \< 10 mcg/l) on the day of blastocyst transfer.

Who can participate

Age range

18 Years – 43 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: * Informed consent form (ICF) dated and signed * Age ≥ 18 and \< 43 years old * Body Mass Index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2 * Less than 4 previous Assisted Reproductive Technologies (ART) cycles * Current pregnancy wish * Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI) Exclusion Criteria: * Simultaneous participation in another clinical study * Previous participation in this study * Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis) * Repeated miscarriages (\> 2 miscarriages) * Untreated and uncontrolled thyroid dysfunction * Tumors of the ovary, breast, uterus, pituitary or hypothalamus * Abnormal vaginal bleeding without a known/diagnosed cause * Ovarian cysts or enlarged ovaries * Fibroid tumors of the uterus incompatible with pregnancy * Malformations of the reproductive organs incompatible with pregnancy * Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin) * Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia * Active smoking * Ongoing pregnancy * Use of carbamazepine, rifampicin or phenytoin * Those unable to comprehend the investigational nature of the proposed…

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

Ongoing pregnancy rate

Timeframe: 7 gestational weeks (+ or - 1 week)

Trial details

NCT IDNCT04806919

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

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