CompletedPhase 1ACTRN12612000731897

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.


Sponsor

Sertac Batioglu

Enrollment

70 participants

Start Date

Mar 22, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 39 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • 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.

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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 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.


Locations(1)

Ankara, Turkey

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ACTRN12612000731897