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A Randomized Trial To Assess The Importance of Human Menopausal Gonadotropin Co-stimulation in In Vitro Fertilization Programs

The impact of human menopausal gonadotropin on follicular fluid hormone levels, embryo quality and IVF outcome in infertile women with mild male factor, unexplained and tubal factor infertility at ages between 25-35, undergoing controlled ovarian stimulation with recombinant FSH versus recombinant FSH+HMG

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001133921
Enrollment
70
Registered
2011-10-31
Start date
2008-11-01
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

Recombinant FSH and HMG (human menopausal gonadotropin) are commonly used in ovarian stimulation protocols. Several studies have evaluated the effectiveness of these two alternatives in IVF and reported conflicting results. The objective of this prospective randomized study is to analyze IVF outcomes of patients undergoing ovarian stimulation with FSH versus FSH-HMG for unexplained, tubal factor and mild male factor infertility.

Interventions

The long COH (controlled ovarian hyperstimulation) protocol is used in which the GnRH analogue (Leuprolide acetate )was administered in a dose of 1 mg/day subcutaneously starting in the mid-luteal phase of the preceding cycle (on the 21st day of preceding cycle). After down regulation (that is, pituitary desensitization) with leuprolide acetate; Arm 1 was stimulated only with subcutaneous recombinant FSH, the starting dose was between 150-450 IU depending on the patient's characteristics and the

The long COH (controlled ovarian hyperstimulation) protocol is used in which the GnRH analogue (Leuprolide acetate )was administered in a dose of 1 mg/day subcutaneously starting in the mid-luteal phase of the preceding cycle (on the 21st day of preceding cycle). After down regulation (that is, pituitary desensitization) with leuprolide acetate; Arm 1 was stimulated only with subcutaneous recombinant FSH, the starting dose was between 150-450 IU depending on the patient's characteristics and the treatment was terminated when 2 or more follicules greater than 17mm in diameter was obtained; Arm 2 was stimulated with subcutaneous recombinant FSH and intramuscular HMG (human menopausal gonadotropin, 1 or 2 ampoules depending on the patient's characteristics) from the beginning and both drugs were continued till 2 or more follicules of 17mm in diameter was obtained; Arm 3 was stimulated with subcutaneous recombinant FSH and intramuscular HMG was added to the stimulation protocol when a 10 mm follicle developed and both drugs were continued till 2 or more follicules of 17mm in diameter was obtained

Sponsors

Gokce Anik Ilhan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
25 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

mild male factor, tubal factor and unexplained infertility

Exclusion criteria

polycystic ovarian syndrome, poor responder patients (defined as having less than four follicles <15mm developed, or cycle cancellations in previous IVF attempts), previous fertilization failure (defined as fertilization rate less than 30% of the MII oocytes in a previous IVF cycle), any systemic, endocrine or metabolic illnesses, diminished ovarian reserve (defined as early follicular phase FSH>15 mIU/mL or AFC<5)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026