CompletedNot Applicable

Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

France455 participantsStarted 2012-11

Plain-language summary

Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.

Who can participate

Age range

18 Years – 36 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 present infertility of more than one year and are candidates for a first or second IVF cycle with or without ICSI for whom HP-hMG is prescribed for COS. * Absence of infertility treatment during the last 3 months before enrolment. * Age: from 18 to 36 years old. * BMI between 18 and 30 kg / m². * Presence of both ovaries accessible to puncture and absence of ovarian or uterine abnormalities. * Male or female infertility. * Ovarian stimulation by HP-hMG with pituitary desensitization by a GnRH agonist or antagonist. * Normal ovarian reserve according to physician habitual evaluation. * Consent to participate of the no-interventional study and signature of the patients' information sheet. Exclusion Criteria: * Presence of a chronic disease, cancer or endocrine disease that could potentially influence the results of the stimulation or that represents a contraindication for ovarian stimulation. * Known endometriosis grade III or IV. * Contraindication to the use of gonadotropins or current pregnancy diagnosed by the clinician. * Recurrent miscarriages, known genetic disease of one of the partners or indication of a preimplantation genetic diagnosis (PGD). * Smoking over than 10 cigarettes / day.´ * Participation in an interventional study at the time of inclusion. * Known poor ovarian response in a previous cycle of stimulation (number of oocyte collected ≤ 3, and / or more than 2 previous IVF/ICSI cycles and / or abnormal result in ovarian rese…

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

Incidence of moderate/severe OHSS

Timeframe: 2-12 weeks

Trial details

NCT IDNCT01703728

SponsorFerring Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-05

View on ClinicalTrials.gov More Ovarian Hyperstimulation Syndrome (OHSS) trials