New fertility shot studied for women over 35
NCT ID NCT07553728
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at a fertility drug called corifollitropin alfa in women aged 36 to 40 who are doing IVF. The goal is to see if the drug is safe and helps produce eggs. Researchers will track side effects and pregnancy rates over one year.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Married women aged 35-39 years scheduled for controlled ovarian stimulation (COS) and IVF/ICSI assisted reproduction using a fixed antagonist protocol with Corifollitropin alfa N02 Injection.
- Ages
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36 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to communicate well with investigators, understand and comply with trial requirements, participate voluntarily, and provide signed informed consent after full understanding. 2. Married women aged 36 to 40 years (exclusive of boundary values). 3. Normal ovarian function: AMH ≥ 1.1 μg/L and basal FSH \< 10 IU/L. 4. Scheduled to undergo controlled ovarian stimulation (COS) and IVF/ICSI using a fixed antagonist protocol combined with Corifollitropin alpha N02 injection. Exclusion Criteria: 1. ≥3 previous cycles of controlled ovarian stimulation (COS) 2. Recurrent pregnancy loss: ≥3 previous pregnancy losses (including spontaneous abortion, biochemical pregnancy, and missed abortion). 3. Repeated implantation failure: ≥3 embryo transfer cycles (fresh or frozen) or failure to achieve clinical pregnancy after transfer of ≥4 high-quality embryos in total. 4. High risk of ovarian hyperstimulation syndrome (OHSS), defined by any of the following: * Diagnosed with polycystic ovary syndrome (PCOS); * Total number of AFC in both ovaries \>20 on Day 2-3 of menstruation; ③ Previous cycle cancellation (including canceled embryo transfer) due to high ovarian response or high OHSS risk; ④ History of OHSS; ⑤ Other conditions judged by the investigator to confer high OHSS risk after comprehensive evaluation. 5. Poor ovarian function, defined by any of the following: ① Previous poor ovarian response (≤3 oocytes retrieved following conventional full-dose gonadotropin stimulation); ② Total AFC in both ovaries \<5. 6. Presence of any reproductive, endocrine, or immune disorders that may affect pregnancy, as assessed by the investigator. 7. Abnormal uterine bleeding. 8. Presence of systemic diseases (e.g., cardiovascular, digestive, neurological, hematological disorders) deemed unsuitable for study participation by the investigator, or severe diseases incompatible with pregnancy. 9. Hypersensitivity or history of allergy to active ingredients or excipients of gonadotropins (Gn), GnRH antagonists, or progesterone preparations, or with documented contraindications to these medications. 10. History of alcoholism, heavy smoking, drug addiction, or substance abuse. 11. Scheduled to undergo preimplantation genetic testing (PGT). 12. Currently participating in another clinical trials and receiving investigational products. 13. Any other conditions deemed by the investigator to render the subject unsuitable for trial participation based on safety considerations.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The hidden handshake that decides whether an embryo implants
- Do infertility treatments leave a metabolic mark on children?
- Could a Woman's biological clock also predict her Heart's future?
- Sperm sorting showdown: can a microchip pick the best sperm for pregnancy?
- Could your genes predict when fertility fades?
- Can virtual reality goggles take the sting out of a fertility procedure?