WithdrawnPhase 3

Progesterone in Luteal Phase Deficiency

Stopped: inability to recruit an adequate number of subjects.

0Started 2017-05-03

Plain-language summary

The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate. The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment. The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).

Who can participate

Age range

20 Years – 35 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 who wish to get pregnant with a previous diagnosis of luteal phase deficiency: * Able and willing to sign the Subject Consent Form and adhere to the study visit schedule; * Age: 20-35 years; * BMI: 18-28 kg/m2; * Inadequate luteal phase (menstrual period shorter than 21 days); * Sub-fertile couple: 12 months of trying to conceive without success. * Normal uterine cavity; * Basal P4 level (day 3 of a previous cycle) ≤ 3ng/ml; * Non-smoking; * Fertile male partner (normal sperm count). Exclusion Criteria: * History of recurrent miscarriage; * Basal P4 level (day 3 of a previous cycle) \> 3ng/ml; * Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ; * Known hypersensitivity to study medication; * Neoplasias (known or suspected breast or genital tract cancer); * Severe impairment of hepatic or renal function; * Use of concomitant medications that might interfere with study evaluations (other hormonal treatment); * Current vaginal infection; * Endometriosis; * PCOS; * Partially or completed block of fallopian tubes; * Hydrosalpinx; * Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events; * Porphyria; * A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy; * Antiphospholipid syndrome; * Diabetes mellitus; * Thyroid diseases or autoimmune conditions; * Hypothalamic dysfunction; * Hyperprolactinaemia; * Infertil…

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 at 12 weeks of gestation

Timeframe: 12 weeks

Trial details

NCT IDNCT02950948

SponsorIBSA Institut Biochimique SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03

View on ClinicalTrials.gov More Luteal Phase Defect trials