Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol

Phase 4

Completed

• Conditions: Female Infertility; Ovarian Insufficiency
• Interventions: Drug: High Dose Clomiphencitrat; Drug: High Dose Placebo; Drug: Low dose Placebo; Drug: Low Dose Clomiphencitrat

• Registration Number: NCT01577472
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Study Start: 2013-08
• Primary Completion: 2017-11-14
• Study Completion: 2017-11-14
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

• Age: >18 years < 43 years
• BMI: ≥ 18 ≤ 32 kg/m2
• Poor responder as defined by ESHRE working group

Exclusion Criteria

• Age < 18 und > 43 years
• Pregnancy
• Breast feeding
• Uterine conditions interfering with endometrial proliferation and embryo implantation (submucous fibroids or polyps)
• Women diagnosed with PCOS according to the Rotterdam criteria
• Hyperprolactinaemia - untreated
• Both ovaries not accessible transvaginally for oocyte pick up
• Ovarian cysts of unclear dignity
• Evidence of hydrosalpinx on ultrasound
• Clinically significant severe systemic disease that are incompatible with pregnancy
• Known or suspected hypersensitivity to the active substances (gonadotrophins, ganirelix, progesterone, clomiphencitrate)
• Untreated thyroid or adrenal disorders
• Bleeding disorders
• Cancer
• Severe renal or hepatic dysfunction
• Necessity to take medication that could influence ovarian stimulation
• History of OHSS in prior IVF cycle

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Clomiphencitrat	High Dose Clomiphencitrat	450 IU Merional® plus 100mg Serophene®
High Dose Placebo	High Dose Placebo	450 IU Merional® plus Placebo
Low Dose Placebo	Low dose Placebo	150 IU Merional® plus Placebo
Low Dose Clomiphencitrat	Low Dose Clomiphencitrat	150 IU Merional® plus 100mg Serophene®

Primary Outcome Measures

Name	Time	Method
number of collected oocytes	1 year

Secondary Outcome Measures

Name	Time	Method
Implantation rate	1 year

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland