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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Testosterone

Transdermal testosterone (20µg/day) from day 24 of the previous cycle until day 2 of the ICSI cycle

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

Transdermal testosterone (20µg/kg/day)from day 24 of the previous cycle to day 2 of the ICSI cycle

Estradiol

Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle

Group Type EXPERIMENTAL

Estradiol

Intervention Type DRUG

Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle

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.

Group Type EXPERIMENTAL

CombEq

Intervention Type DRUG

(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.

Interventions

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Testosterone

Transdermal testosterone (20µg/kg/day)from day 24 of the previous cycle to day 2 of the ICSI cycle

Intervention Type DRUG

Estradiol

Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Testopatch, Pierre Fabre Ibérica S.A. Alcis 100, Chiesi España Microdiol, MERCK SHARP & DOHME Meriestra 2mg, Novartis Farmacéutica, S.A.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No