NCT01577472

Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol

Prospective Randomized Phase IV Study Comparing the Effect of Adding Clomiphencitrate Versus Placebo to a High Dose Versus a Minimal Dose GnRH Antagonist Protocol on the Number of Oocytes Collected From Women That Are Poor Responders

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the oocyte yield of infertile women with suspected or known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional® starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT has been conducted to compare the reproductive outcome of patients with POR as defined by the ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an additional increment of endogenous GT thus increasing the oocytes yield after controlled ovarian stimulation due to higher endogenous gonadotropin secretion.

Conditions

• Female Infertility
• Ovarian Insufficiency

Interventions

Type	Name	Description
DRUG	High Dose Clomiphencitrat	100mg of clomiphencitrate(Serophene®) are added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
DRUG	Low Dose Clomiphencitrat	100mg of clomiphencitrate(Serophene®) are added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
DRUG	High Dose Placebo	Placebo is added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
DRUG	Low dose Placebo	Placebo is added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-11-14
• Completion: 2017-11-14
• First posted: 2012-04-13
• Last updated: 2018-12-04

Locations

1 site across 1 country: Switzerland