Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients

NCT ID: NCT00870025

Last Updated: 2015-04-22

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

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There is a decline in androgen concentration with ovarian aging. Also, ovarian response to COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian androgen concentration. A physiological way to induce androgen synthesis within the ovary is to stimulate theca cells androgen production by hCG stimulation. By doing this in the previous cycle we might expect a better response to COH.

Detailed Description

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Conditions

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Ovarian Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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hCG

200 IU rec hCG s.c./5 days, 4 doses prior to onset of COH

Group Type ACTIVE_COMPARATOR

human chorionic gonadotropin

Intervention Type BIOLOGICAL

200 IU, sc, every 5 days, 4 doses

placebo

Intervention Type BIOLOGICAL

diluent, every 5 days, s.c., 4 doses

placebo

similar injection at same time points with similar diluent but no hCG

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

diluent, every 5 days, s.c., 4 doses

Interventions

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human chorionic gonadotropin

200 IU, sc, every 5 days, 4 doses

Intervention Type BIOLOGICAL

placebo

diluent, every 5 days, s.c., 4 doses

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* previous IVF cycle with 5 or less mature follicles or 5 or less oocyte retrieved

Exclusion Criteria

* 42 years or older
* BMI \<18 or \>30
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan A Garcia-Velasco, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Locations

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IVI-Madrid

Madrid, , Spain

Site Status

Countries

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Spain

References

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Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.

Reference Type BACKGROUND
PMID: 16517559 (View on PubMed)

Massin N, Cedrin-Durnerin I, Coussieu C, Galey-Fontaine J, Wolf JP, Hugues JN. Effects of transdermal testosterone application on the ovarian response to FSH in poor responders undergoing assisted reproduction technique--a prospective, randomized, double-blind study. Hum Reprod. 2006 May;21(5):1204-11. doi: 10.1093/humrep/dei481. Epub 2006 Feb 13.

Reference Type BACKGROUND
PMID: 16476678 (View on PubMed)

Other Identifiers

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IVIMAD-LO-09-2008-01

Identifier Type: -

Identifier Source: org_study_id

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