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Clinical Trials/NCT01577472
NCT01577472
Completed
Phase 4

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

University Hospital, Basel, Switzerland1 site in 1 country117 target enrollmentAugust 2013

Overview

Phase
Phase 4
Intervention
High Dose Clomiphencitrat
Conditions
Female Infertility
Sponsor
University Hospital, Basel, Switzerland
Enrollment
117
Locations
1
Primary Endpoint
number of collected oocytes
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
November 14, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

High Dose Clomiphencitrat

450 IU Merional® plus 100mg Serophene®

Intervention: High Dose Clomiphencitrat

Low Dose Clomiphencitrat

150 IU Merional® plus 100mg Serophene®

Intervention: Low Dose Clomiphencitrat

High Dose Placebo

450 IU Merional® plus Placebo

Intervention: High Dose Placebo

Low Dose Placebo

150 IU Merional® plus Placebo

Intervention: Low dose Placebo

Outcomes

Primary Outcomes

number of collected oocytes

Time Frame: 1 year

Secondary Outcomes

  • Implantation rate(1 year)

Study Sites (1)

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