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Different treatment modalities for women with polycystic ovary like phenotype undergoing assisted reproduction

A randomized controlled trial of Hp-hMG versus recombinant FSH for women with polycystic ovary like phenotype undergoing ART, comparing the number of intermediate-sized follicles (15-17 mm) between groups.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000731897
Enrollment
70
Registered
2012-07-09
Start date
2009-03-22
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

A differential follicular response is observed with the use of HP-hMG, resulting in fewer intermediate-sized follicles. The clinical pregnancy rate obtained with HP-hMG in PCO subjects undergoing ICSI is similar with rFSH.

Interventions

Arm 1: highly purified HMG; Arm2: recombinant FSH HP-hMG administered by intramuscular (i.m.) injections, rFSH subcutaneausly, patients underwent controlled ovarian hyperstimulation following down-regulation with a gnrh agonist in a long protocol. leuprolide acetate, 1mg /days subcutaneausly (lucrine; abbott) was initiated 5-7 days before the estimated start of next menses and continued as 0.5 mg/days until end of gonadotropin administration. gonadotropin administration was initiated when do

Arm 1: highly purified HMG; Arm2: recombinant FSH HP-hMG administered by intramuscular (i.m.) injections, rFSH subcutaneausly, patients underwent controlled ovarian hyperstimulation following down-regulation with a gnrh agonist in a long protocol. leuprolide acetate, 1mg /days subcutaneausly (lucrine; abbott) was initiated 5-7 days before the estimated start of next menses and continued as 0.5 mg/days until end of gonadotropin administration. gonadotropin administration was initiated when down-regulation was confirmed by using transvaginal ultrasound showing no ovarian cysts, and endometrium with a thickness of <5 mm or serum estradiol <50 pg/ml. the starting dose of HP-hMG or rFSH was 150 iu for the first three days, followed by according to the patient’s follicular response. choriongonadotropin alfa, 250 microgram subcutaneausly (ovitrelle; serono), was administered within a day of observing three or more follicles of greather than or equal to18 mm diameter to induce final follicular maturation.

Sponsors

Sertac Batioglu
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
No

Inclusion criteria

Group of infertile women aged 18-39 years who manifest sonographic evidence of polycystic ovarian morphology (POM) but who do not have any clinical manifestation of the polycystic ovarian syndrome (PCOS)

Exclusion criteria

early follicular phase serum FSH levels less than or equal to 12 IU/l and abnormal levels of prolactin and partners with semen abnormalities requiring TESE.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026