Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders (FOLLPRIM)

February 27, 2014 updated by: Instituto de Investigacion Sanitaria La Fe

Prospective Randomized Controlled Trial of Antral Follicle Priming Prior to IVF-ICSI in Previously Diagnosed Low Responders.

The aim of this study is to compare the effectiveness of testosterone,estradiol and a combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low responder patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During controlled ovarian hyperstimulation (COH), most of the early antral follicles are required to grow coordinately. Marked follicular size discrepancies during COH imply that an important number of follicles undergo unsatisfactory maturation. It has been proved that follicular priming with estradiol during the luteal phase of the cycle prior to COH or testosterone treatment during the early follicular phase of the COH cycle may increase the amount of oocytes and embryos retrieved. Nevertheless there are no prospective studies comparing such approaches. The present study consist of two phases:

The present study consists of two different phases:

  • Phase I: (Non randomized) Identification of confirmed low responder patients. Potential low responder patients will be subjected to an standardized ovarian hyperstimulation protocol
  • Phase II: (Randomized) those patients, once confirmed as low responders, will be offered the opportunity to enter the interventional part of the study, being randomized to three different treatment groups: estradiol, testosterone or combined progestagens and estrogens prior to the IVF-ICSI cycle. The previous cycle (phase I) will be used as a self-control for each patient.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

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

  • Spain
      • Valencia, Spain, 46026
        • La Fe University Hospital. Department of Obstetrics and Gynecology

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 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Phase 1 (Non randomized. The patient must fit the first plus at least other 2 criteria)

    • Infertility requiring an IVF/ICSI treatment
    • Age ≥ 38 years
    • Basal FSH ≥ 10 mUI/ml (day 3 of the cycle)
    • Serum AMH ≤ 5 pmol/l
    • Antral follicular count ≤ 6 (day 3 of the cycle)

  2. Phase 2 (Randomized. The patient must fit at least one criterion regarding the day of GNRH analogue administration during the cycle performed in Phase 1)

    • Less than 4 follicles which mean diameter measuring more than 16mm
    • Serum estradiol levels ≤ 500 pg/ml
    • 4 MII or less than 4 MII oocytes retrieved

Exclusion Criteria:

  • Patients suffering of endometriosis
  • Patients having progesterone levels ≤ 4 ng/ml (day 21 of the cycle)
  • Patients having a partner affected by severe oligo/astheno/teratozoospermia

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testosterone
Transdermal testosterone (20µg/day) from day 24 of the previous cycle until day 2 of the ICSI cycle
Drug: Testosterone
Transdermal testosterone (20µg/kg/day)from day 24 of the previous cycle to day 2 of the ICSI cycle
Other Names:
  • Testopatch, Pierre Fabre Ibérica S.A.
Experimental: Estradiol
Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle
Drug: Estradiol
Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle
Other Names:
  • Alcis 100, Chiesi España
Experimental: CombEq
  • (150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI
  • Estradiol valerate 4 mg/day during 10 days, starting the second day of the cycle prior to the ICSI cycle.
Drug: CombEq

(150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI.

Valerate estradiol 4mg/day during 10 days, starting the second day of the cycle prios to the ICSI cycle.

Other Names:
  • Microdiol, MERCK SHARP & DOHME
  • Meriestra 2mg, Novartis Farmacéutica, S.A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of MII oocytes retrieved
Time Frame: 36h after GnRH analogue administration
36h after GnRH analogue administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Total number of follicles punctured
Time Frame: 36h after GnRH analogue administration
36h after GnRH analogue administration
Total number of oocytes retrieved
Time Frame: 36h after GnRH analogue administration
36h after GnRH analogue administration
Total number of viable embryos
Time Frame: 48h after follicular puncture
48h after follicular puncture
Serum and Follicular hormonal levels (testosterone, androstenedione, estradiol)
Time Frame: 36h after GnRH analogue administration
36h after GnRH analogue administration
Granulosa cells genetic expression profile
Time Frame: 36h after GnRH analogue administration
36h after GnRH analogue administration
Implantation rate
Time Frame: 15 days after embryo transfer
15 days after embryo transfer
Pregnancy rate
Time Frame: 15 days after embryo transfer
15 days after embryo transfer
Clinical pregnancy rate
Time Frame: 5 weeks after embryo transfer
5 weeks after embryo transfer

Collaborators and Investigators

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

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: César Díaz, M.D., La Fe University Hospital. Department of Obstetrics and Gynecology
  • Study Director: Antonio Pellicer, Professor, La Fe University Hospital. Department of Obstetrics and Gynecology
  • Study Chair: Alicia Marzal, M.D., La Fe University Hospital. Department of Obstetrics and Gynecology

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

June 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 7, 2011

First Posted (Estimate)

March 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-018009-26 (EudraCT Number)

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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