CompletedPhase 3

To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)

397 participantsStarted 2006-12-28

Plain-language summary

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

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: * Females of couples with an indication for COS and IVF or ICSI; * \>=18 and \<= 36 years of age at the time of signing informed consent; * Body weight \<= 60 kg and BMI \>= 18 and \<= 32 kg/m\^2; * Normal menstrual cycle length: 24-35 days; * Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed); * Willing and able to sign informed consent. Exclusion Criteria: * History of/or any current (treated) endocrine abnormality; * History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS); * History of/or current polycystic ovary syndrome (PCOS); * More than 20 basal antral follicles \<11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5); * Less than 2 ovaries or any other ovarian abnormality (including endometrioma \> 10 mm; visible on USS); * Presence of unilateral or bilateral hydrosalphinx (visible on USS); * Presence of any clinically relevant pathology affecting the uterine cavity or fibroids \>= 5 cm; * More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable); * History of non- or low ovarian response to FSH/hMG treatment; * History of recurrent miscarriage (3 or more, even when unexplained); * FSH \> 12 IU/L or LH \> 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5); * Any clinically relevant abnormal laboratory value based on a sample…

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

Number of Cumulus-oocyte-complexes Retrieved, Per Attempt

Timeframe: One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)

Trial details

NCT IDNCT00702845

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07-07

Results submitted2015-04-10

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