An interventional study of Cease progsterone at 5 and control group: progesterone 8 in Pregnant Women, sponsored by IVI Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by IVI Madrid · Not applicable, Interventional, and Treatment
There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.
The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.
Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.
All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.
Inclusion criteria:
Exclusion criteria:
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy
Other: Cease progsterone at 5
Progesterone will be given until 8 weeks of pregnancy
Other: control group: progesterone 8
Cease administration of progsterone at first US at 5 weeks
Control group: progesterone until 8 weeks of pregnancy
Number of Bleeding Episodes
Number of bleeding episodes up to a year
Time frame: Up to year
Progesterone during 1st trimester
| Milestone | Progesterone 5 Weeks | Control Group : Progesterone 8 Weeks |
|---|---|---|
| Started | 100 | 100 |
| Completed | 100 | 100 |
| Not completed | 0 | 0 |
Number of bleeding episodes up to a year
| Episodes of bleeding | Control Group : P4 8 Weeks | Study Group |
|---|---|---|
| Number of Bleeding Episodes | 8 ± 10 | 8 ± 10 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group : P4 8 Weeks | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Study Group: P4 5 Weeks | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
Women
| Age, Categorical(Participants) | Progesterone 5 Weeks | Control Group : P4 8 Weeks | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 100 | 100 | 200 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Progesterone 5 Weeks | Control Group : P4 8 Weeks | Total |
|---|---|---|---|
| Female | 100 | 100 | 200 |
| Male | 0 | 0 | 0 |
| Bleeding Episodes(Bleeding episodes) | Progesterone 5 Weeks | Control Group : P4 8 Weeks | Total |
|---|---|---|---|
| Mean | 8 ± 4 | 8 ± 4 | 8 ± 4 |
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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IVI Madrid