Protocol Number: 07-CH-0193

Title:

Use of GnRH Antagonist to Preserve Ovarian Function in Women Undergoing Chemotherapy

Number:

07-CH-0193

Summary:

This study will examine whether the drug cetrorelex acetate (Cetrotide[Registed Trademark]) can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are known to cause a change in women's periods or to cause menstruation to stop completely, so that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower hormone levels and stop periods in patients undergoing in vitro fertilization treatments. This study will see if making the ovaries inactive may protect them from being affected by certain cancer drugs, and thus preserve fertility.

Women up to age 21who have begun menstruating, who have their uterus and at least one functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan, nitrogen mustard or L-phenalanin mustard may be eligible for this study.

Participants undergo the following procedures during this 24-month study:

Baseline evaluation

-Medical history, physical examination and blood and urine tests

-Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for future fertility

-3D ultrasound of abdomen

-DEXA scan to evaluate bone density

Assignment to treatment with:

-Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone, or

-Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin once a day for six menstrual cycles

Evaluations

-Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of cetrorelex acetate injections

-DEXA scan - after 6 months of cetrorelex acetate injections

-Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses - every 3 months during first year, every 6 months during second year

-Questionnaire to monitor changes and quality of life - every 3 months during first year, every 6 months during second year.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Recruitment has not started

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

GnRH Antagonist

Premature Ovarian Failure

Fertility

Chemotherapy

Recruitment Keyword(s):

Premature Ovarian Failure

POF

Chemotherapy

Condition(s):

Ovarian Function

Preservation of Ovarian Function

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: GnRH antagonist

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Oktay KH, Yih M. Preliminary experience with orthotopic and heterotopic transplantation of ovarian cortical strips. Semin Reprod Med. 2002 Feb;20(1):63-74.

Donnez J, Dolmans MM, Demylle D, Jadoul P, Pirard C, Squifflet J,Martinez-Madrid B, van Langendonckt A. Livebirth after orthotopic transplantation of cryopreserved ovarian tissue. Lancet. 2004 Oct 16-22;364(9443):1405-10. Erratum in: Lancet. 2004 Dec 4;364(9450):2020.

Teinturier C, Hartmann O, Valteau-Couanet D, Benhamou E, Bougneres PF. Ovarian function after autologous bone marrow transplantation in childhood: high-dose busulfan is a major cause of ovarian failure. Bone Marrow Transplant. 1998 Nov;22(10):989-94.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009