Predicting Ovarian Response in Artificial Insemination With Low Stimulation

December 12, 2012 updated by: M. Bloemendal, Isala
This large prospective multi-center cohort study aims to identify patient's characteristics that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU recombinant FSH.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A multi-center, open-label, prospective cohorts study. Patients with a regular indication for COH/IUI (controlled ovarian stimulation/ intra uterine insemination) will be asked to participate. Patient's characteristics will be documented including age, weight, BMI, smoking status, cycle day 2 3 or 4 FSH /Estradiol levels, antral follicle count, and AMH. AMH and FSH/Estradiol will be determined centrally after completion of inclusion of all patients in the study. All patients will receive a fixed 75 IU recFSH per day conform normal stimulation protocol starting from cycle day 3, 4 or 5 after exclusion of ovarian cysts by ultrasound. Ovarian response will be documented by ultrasound only. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Cancellation criteria will be defined according to the national guidelines provided by the NVOG (7).

Study Type

Observational

Enrollment (Anticipated)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • PO Box 10400
      • Zwolle, PO Box 10400, Netherlands, 8000 GK
        • Recruiting
        • Isala Klinieken
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ben Cohlen, dr.
    • PO box 1350
    • PO box 22660
      • Amsterdam, PO box 22660, Netherlands, 1100 DD
        • Not yet recruiting
        • AMC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fulco van der Veen, prof. dr.
    • PO box 7057
      • Amsterdam, PO box 7057, Netherlands, 1007 MB
        • Not yet recruiting
        • VUmc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cornelis Lambalk, prof. dr.
    • PO box 85500
      • Utrecht, PO box 85500, Netherlands, 3508 GA
    • PO box 90151
      • Tilburg, PO box 90151, Netherlands, 5000 LC
        • Not yet recruiting
        • st Elizabeth Gasthuis
        • Contact:
        • Principal Investigator:
          • Jesper Smeenk, dr.
    • Po 95500
      • Amsterdam, Po 95500, Netherlands, 1090 HM
        • Not yet recruiting
        • OLVG
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eugenie Kaaijk, dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subfertile couples presenting at fertility clinics with an indication for IUI in stimulated cycles

Description

Inclusion Criteria:

  • couples with unexplained or mild male subfertility (1-3) and a spontaneous chance of conception below 40% (Hunault score).
  • Unexplained subfertility including minimal to mild endometriosis (AFS grade 1 or 2) is defined as the failure to conceive after at least one year of unprotected intercourse whereas the standard fertility work-up was unable to detect any factors that might influence fertility negatively.
  • semen analysis should be normal according to the WHO guidelines (8),
  • ovulation should be documented (by BBT charts, ovulation detection by ultrasound or normal luteal progesterone values),
  • tubal patency should be confirmed (HSG, laparoscopy or fertiloscopy) and when a postcoital test was performed a cervical factor should have been excluded.
  • Mild male subfertility is defined as abnormal semen parameters according to the WHO (8) but an average total motile sperm account before processing of at least 10 million.

Exclusion Criteria:

  • Hunault score ≥ 40%
  • Endometriosis AFS grade 3 or 4
  • Contra-indications for the use of gonadotrophins (cysts larger than 2 cm, allergy for gonadotrophins)
  • Total motile sperm count after sperm processing below 1 million
  • Women aged younger than eighteen years or older than 45 years.
  • Previous treatment with COH/IUI for treating current subfertility
  • Unable to speak or read the Dutch language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subfertile couples

Subfertile couples presenting at fertility clinics with an indication for IUI in stimulated cycles

All patients will receive a fixed 75 IU recombinant follicle stimulating hormone per day conform normal stimulation protocol starting from cycle day 3, 4 or 5. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Patients will be followed for the time of one menstrual cycle.
Drug: Follicle Stimulating Hormone
All patients will receive a fixed 75 IU rec follicle stimulating hormone per day subcutaneous injection stimulation protocol starting from cycle day 3, 4 or 5. The intervention done in this study is conform normal stimulation protocol and is not the target of this study.
Other Names:
  • Puregon [Merck Sharp & Dohme bv]
  • Gonal -F [Serono Benelux bv]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the relationship between AMH serum levels and ovarian response
Time Frame: one menstrual cycle, one month
(defined by the number of dominant follicles >15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH. All follicles > 11 mm will be documented
one menstrual cycle, one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the relationship between age, weight, BMI, smoking, AFC, FSH/E2 on CD3 and ovarian response
Time Frame: one menstrual cycle, one month
(defined by the number of dominant follicles >15mm) in IUI cycles stimulated with a fixed dose of 75 IU recFSH.
one menstrual cycle, one month
Pregnancy rate per started cycle.
Time Frame: three months
From start of the menstrual cycle until a positive heartbeat registered at 12 weeks of gestation.
three months
Multiple pregnancy rate per started cycle.
Time Frame: three months
From start of the menstrual cycle until positive heartbeats registered at 12 weeks of gestation.
three months
Miscarriage rate per started cycle.
Time Frame: five months
miscarriage up to 16 weeks of gestation
five months
Cancellation rate per stimulated cycle
Time Frame: one menstrual cycle, one month
one menstrual cycle, one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Collaborators

Merck Serono International SA

Investigators

  • Principal Investigator: Ben Cohlen, dr., Isala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (ESTIMATE)

August 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRORAILS trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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