Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol (CANTAPOR)

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Female Infertility; Ovarian Insufficiency

Treatments: Drug: High Dose Placebo; Drug: Low dose Placebo; Drug: Low Dose Clomiphencitrat; Drug: High Dose Clomiphencitrat

Study type: Interventional

Funder types: Other

Identifiers

NCT01577472

CANTAPOR_2012

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 4 patient groups, including a placebo group

High Dose Clomiphencitrat

Active Comparator group

Description:

450 IU Merional® plus 100mg Serophene®

Treatment:

Drug: High Dose Clomiphencitrat

Low Dose Clomiphencitrat

Active Comparator group

Description:

150 IU Merional® plus 100mg Serophene®

Treatment:

Drug: Low Dose Clomiphencitrat

High Dose Placebo

Placebo Comparator group

Description:

450 IU Merional® plus Placebo

Treatment:

Drug: High Dose Placebo

Low Dose Placebo

Placebo Comparator group

Description:

150 IU Merional® plus Placebo

Treatment:

Drug: Low dose Placebo