Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure

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/PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2015-10-31

Brief Summary

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Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure (POF), resulting in an important decrease of the long-term quality of life and an increase of morbidity. A recent study showed that the patients treated by alkylating agents had a 4.52 fold higher risk to lose their ovarian function compared with those who were treated by other agents. The rate of POF after treatment ranged from 40 to 80%, according to the age of the patients and the total doses administered.

Young women who experience POF have to face with the prospects of infertility and to consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage by administering of protective therapy during chemotherapy represents an attractive option for these patients.

The aim of this study is to evaluate the protective effect on the ovarian function of the gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data in human are, however, highly controversial.

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Detailed Description

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Conditions

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Fertility Preservation Alkylating Agents Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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Triptorelin

Triptorelin: intramusculAR injection every 3 months

Intervention Type DRUG

Norethisterone acetate

5 mg/day per os until during chemotherapy

Intervention Type DRUG

Other Intervention Names

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Decapeptyl Primolut

Eligibility Criteria

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Inclusion Criteria

* Women between 18 and 45 years old with lymphoma.
* Menarche \>2year
* Subject treated by chemotherapy-induced ovarian failure including alkylant agents (except less than 8 ABVD)
* Presence of both ovaries (ovarian biopsy or hemiovariectomy for cryopreservation before treatment is accepted).
* Ability to give written informed consent

Exclusion Criteria

* Hormonal-sensible malignancy
* Chemotherapy or radiotherapy before the inclusion in the study
* Pelvic irradiation including the ovaries or TBI
* Pregnancy
* Patient weight above 110 kg
* Anamnesis of thrombo-embolic processes
* Severe hepatic or renal insufficiency
* Systolic blood pressure \>15mmHg or diastolic blood pressure \> 90mmHg
* Contraindication of IM injection
* Relevant ovarian abnormalities (Functional follicular cyst are tolerated)
* Anamnesis of premature ovarian failure or irregular cycle (repeated amenorrhoea \>2 months)
* Dubin-Johnson and Rotor Syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No