Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol

NCT ID: NCT01577472

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-11-14

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.

Conditions

Female Infertility; Ovarian Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High Dose Clomiphencitrat

450 IU Merional® plus 100mg Serophene®

Group Type: ACTIVE_COMPARATOR

High Dose Clomiphencitrat

Intervention Type: DRUG

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).

Low Dose Clomiphencitrat

150 IU Merional® plus 100mg Serophene®

Group Type: ACTIVE_COMPARATOR

Low Dose Clomiphencitrat

Intervention Type: DRUG

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).

High Dose Placebo

450 IU Merional® plus Placebo

Group Type: PLACEBO_COMPARATOR

High Dose Placebo

Intervention Type: DRUG

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).

Low Dose Placebo

150 IU Merional® plus Placebo

Group Type: PLACEBO_COMPARATOR

Low dose Placebo

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca E Moffat, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Women's Clinic

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

Moffat R, Hansali C, Schoetzau A, Ahler A, Gobrecht U, Beutler S, Raggi A, Sartorius G, De Geyter C. Randomised controlled trial on the effect of clomiphene citrate and gonadotropin dose on ovarian response markers and IVF outcomes in poor responders. Hum Reprod. 2021 Mar 18;36(4):987-997. doi: 10.1093/humrep/deaa336.

Reference Type: DERIVED

PMID: 33367742 (View on PubMed)

Other Identifiers

CANTAPOR_2012

Identifier Type: -

Identifier Source: org_study_id