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Completed

NCT Number: NCT01577472

Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol

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.

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Ovarian Insufficiency Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Dose Clomiphencitrat

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

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

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

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).

Primary outcomes

  1. number of collected oocytes

    Time frame: 1 year

Secondary outcomes

  1. Implantation rate

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: CANTAPOR

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2012
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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