NCT01577472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

4.3 years

First QC Date

April 5, 2012

Last Update Submit

December 3, 2018

Conditions

Female InfertilityOvarian Insufficiency

Keywords

female infertilitypoor ovarian responsecontrolled ovarian hyperstimulationIVFAntagonist protocol

Outcome Measures

Primary Outcomes (1)

  • number of collected oocytes

    1 year

Secondary Outcomes (1)

  • Implantation rate

    1 year

Study Arms (4)

High Dose Clomiphencitrat

ACTIVE COMPARATOR

450 IU Merional® plus 100mg Serophene®

Drug: High Dose Clomiphencitrat

Low Dose Clomiphencitrat

ACTIVE COMPARATOR

150 IU Merional® plus 100mg Serophene®

Drug: Low Dose Clomiphencitrat

High Dose Placebo

PLACEBO COMPARATOR

450 IU Merional® plus Placebo

Drug: High Dose Placebo

Low Dose Placebo

PLACEBO COMPARATOR

150 IU Merional® plus Placebo

Drug: Low dose Placebo

Interventions

High Dose ClomiphencitratDRUG

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).

High Dose Clomiphencitrat
Low Dose ClomiphencitratDRUG

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).

Low Dose Clomiphencitrat
High Dose PlaceboDRUG

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).

High Dose Placebo
Low dose PlaceboDRUG

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).

Low Dose Placebo

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: \>18 years \< 43 years
  • BMI: ≥ 18 ≤ 32 kg/m2
  • Poor responder as defined by ESHRE working group

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33367742DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Rebecca E Moffat, MD

    University Hospital Basel, Women's Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 13, 2012

Study Start

August 1, 2013

Primary Completion

November 14, 2017

Study Completion

November 14, 2017

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

CH(1)