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
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.
Investigators
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)