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Ganirelix in insemination cycles of women with premature luteinization

The effect of gonadotropin-releasing hormone antagonist in unsuccessful controlled ovarian stimulation and intrauterine insemination cycles with premature luteinization

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000153819
Enrollment
114
Registered
2012-02-03
Start date
2007-06-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

To observe the effects of ganirelix on controlled ovarian stimulation and intrauterine insemination (COS/IUI) cycles in women who had premature luteinization (PL) in their first failed cycles.

Interventions

Recombinant FSH (rFSH) treatment with a starting dose of 50-75 IU per day was commenced by the day 3 of menstrual cycle a) according to low dose step-up protocol (Speroff L, Fritz MA (2005). Assisted reproductive technologies. In Clinical Gynecologic Endocrinology and Infertility, 7th ed., pp. 1216–1274) b) by a once daily subcutaneous injection in the abdominal wall, injected by the patient using pen c) until the follicle diameter reach 20 mm (usually within 7-14 days) From day 7 onwards, the

Recombinant FSH (rFSH) treatment with a starting dose of 50-75 IU per day was commenced by the day 3 of menstrual cycle a) according to low dose step-up protocol (Speroff L, Fritz MA (2005). Assisted reproductive technologies. In Clinical Gynecologic Endocrinology and Infertility, 7th ed., pp. 1216–1274) b) by a once daily subcutaneous injection in the abdominal wall, injected by the patient using pen c) until the follicle diameter reach 20 mm (usually within 7-14 days) From day 7 onwards, the gonadotropin dose was adjusted and individualized based on the follicular growth observed by ultrasonography. Ganirelix, GnRH antagonist, was administered a) at the dose of 0.25 mg per day starting from the day in which a follicle > 14 mm in mean diameter was visualized at ultrasound scan (flexible multiple dose protocol) b) by subcutanous injection c) till the follicle reaches 18 mm (usually within 4-5 days)

Sponsors

Mersin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 38 Years
Healthy volunteers
No

Inclusion criteria

The main inclusion criteria were age between 18 and 38 years, primary or secondary infertility lasting for > 12 months, normal thyroid function, normal prolactin levels and normal uterine cavity and bilateral tubal patency assessed by hysterosalpingography

Exclusion criteria

severe male factor infertility (sperm concentration <10 x106 or strict morphology <4%), stage III or IVendometriosis, baseline FSH > 10 IU/L.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026