TerminatedPhase 4

Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Stopped: The trend in LPS treatment tends to increase the dosage of progesterone in FET-HRT, this study was designed 5 years ago.

China172 participantsStarted 2019-05-31

Plain-language summary

The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).

Who can participate

Age range

20 Years – 38 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: Participants are eligible to be included in the study only if all the following criteria apply: * Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions * Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site) * Participants have received estradiol valerate for no more than 20 days * Participants have a transitional-endometrium of greater than or equal to 8 millimeter * Participants have normal uterine cavity * Participants can give signed informed consent * Participants are willing to follow the study protocol and able to complete the study Exclusion Criteria: * Participants are willing to follow the study protocol and able to complete the study * Participants with greater than or equal to three previously failed cycles of ET * Participants with diseases that cannot tolerate pregnancy * Hydrosalpinx * Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996) * Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin * History of recurrent miscarriages * Vaginitis * Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions * Known or suspected progestogen-dependent neoplasm * Participation in another clinical trial within the past 30 days * Con…

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: 8 to 10 weeks after embryo transfer

Trial details

NCT IDNCT03858049

SponsorMerck KGaA, Darmstadt, Germany

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-27

Results submitted2022-09-01

View on ClinicalTrials.gov More Infertility trials