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Mild ovarian stimulation in women with poor ovarian response undergoing IVF and ICSI.

Mild Ovarian Stimulation Strategy versus Standard Stimulation in Poor Responder Women Undergoing IVF and ICSI (PRIMA). International Multicenter Randomised Controlled Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26313
Enrollment
400
Registered
2010-11-10
Start date
2010-11-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor ovarian response

Interventions

Group (1) will be pre-treated with oral contraceptive pills (OCP) started on cycle day 2-3 of the preceding cycle for a variable period of 14-21 days. The date of the last OC intake will be decided by
Progestan, Organon
200 mg, three times d

Sponsors

Non
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Valid indication for IVF or ICSI; 2. Patients with expected or non expected poor response: A. Expected: i. Aged women > 35 years; ii. And/or women who have a raised basal day 3 FSH level > 10 IU/mL irrespective of age; iii. And/or women who have a low antral follicular count 3000 IU FSH for follicle growth; iii. And/or women who have low oocyte yield < 3-5 follicles despite high daily stimulation dose; iiii. And/or women who have their IVF cycle cancelled due to a low estradiol level < 300-850 pg/ml. 3. Pre-wash total motile sperm count above 10 million or a post-wash total motile sperm count above 1 million.

Exclusion criteria

Exclusion criteria: 1. Women > 43 years old; 2. Polycystic ovary syndrome or any other anovulation; 3. Endocrino pathological disease like: Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea, hypothyroid, diabetes mellitus type; 4. If not willing or able to sign the consent form.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy (OPR) per women randomised (defined as a viable pregnancy of at least 10 weeks of gestation).

Secondary

MeasureTime frame
1. Clinical pregnancy, defined as any registered embryonic heartbeat at sonography; 2. Biochemical pregnancy ((defined as an increase in serum HCG or a positive pregnancy test); 3. Multiple pregnancy, defined as registered heartbeat of at least two foetuses at 6-8 weeks of gestation; 4. Miscarriage rate; 5. Fertilization rate; 6. Number of oocytes; 7. Number of metaphase II oocytes; 8. Number of embryos; 9. Number of ET; 10. Number of embryos frozen; 11. Total FSH dose used for ovarian stimulation; 12. Cancellation rate; 13. Drop-out rate; 14. Costs.

Contacts

Public ContactMohamed A.F. Youssef

Post Office Box 109

mmfatah@yahoo.com / m.a.youssef@amc.uva.nl+20 2148088826

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)