At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 131 enrolled

Drug / intervention

Recombinant human follicle stimulating hormone (r-hFSH) +1 moredrug

Likely dose

Recombinant human follicle stimulating hormone (r-hFSH) 0.1 milligramfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01110707

NCT01110707Phase 2Completed

Compare CT.gov

Lutropin Alpha in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve: Comparative Study, in Phase II, With Parallel Control

Merck KGaA, Darmstadt, Germany·interventional·Posted Apr 27, 2010·Updated Mar 27, 2018

In Brief

A Phase 2 clinical trial evaluating Recombinant human follicle stimulating hormone (r-hFSH) and Recombinant human luteinizing hormone (r-hLH) for Infertility and Ovulation Induction. Completed, enrolled 131 participants across 1 site.

Detailed Summary

This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfertility, Ovulation Induction

CountriesSpain

Collaborators--

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2005

Primary CompletionNov 2006

First PostedApr 2010

TodayJul 2026

First PostedApr 27, 2010

Enrollment StartJan 10, 2005

Primary CompletionNov 15, 2006

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 16.2 years ago

Interventions

Recombinant human follicle stimulating hormone (r-hFSH)drug

Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]).

Recombinant human luteinizing hormone (r-hLH)drug

Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.