Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX) (NCT03701490) | Clinical Trial Compass
CompletedPhase 2
Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX)
Spain213 participantsStarted 2019-03-12
Plain-language summary
The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.
Who can participate
Age range
18 Years – 49 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:
* Women attending the clinics to undergo a frozen blastocyst embryo transfer, having given written informed consent, with the following characteristics:
* 18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);
* 18-37 years of age for subjects undergoing ET with autologous oocytes (both inclusive);
* BMI \<32 kg/m2;
* Adequate endometrium preparation (Endometrial thickness \> 7 mm) and E2 levels ( \>100 pg/ml) on the day progesterone treatment is started;
* P4 levels \<1.5 ng/ml on the day progesterone treatment is started;
* Transfer of 1 or 2 frozen embryos at blastocyst stage
* Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;
* Semen from ejaculation either from the partner or from a bank
* ≤ 3 previous ET (frozen and fresh) with no pregnancy
* Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).
Exclusion Criteria:
* Presence of functional follicles \> 10 mm of diameter on the day progesterone treatment is started;
* Intramural uterine fibroids that distort the uterine cavity or polyps \>1 cm;
* Stage III or IV endometriosis (endometriomas);
* Hydrosalpinx;
* Pregnancy or lactation
* Malformations of the sexual organs incompatible with pregnancy;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Known allergy to progesterone preparations or their excipients;
* Uncontrolled adrenal or thyroid dysfunction;
* Undiagnosed vaginal …
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
1
Clinical pregnancy rate
Timeframe: 4-5 weeks after progesterone treatment start.