Ovarian Function Clinical Trial
Official title:
Use of the GnRH Agonist Leuprolide Acetate (Lupron(Registered Trademark)) to Preserve Ovarian Function in Women Undergoing Chemotherapy
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.
As a result of the inability of female germ cells to regenerate after injury, a number of
chemotherapeutic agents induce premature ovarian failure in the majority of reproductive age
women who receive them. The long-term survival for these women has increased with more
effective chemotherapies, making iatrogenic ovarian failure and infertility an increasingly
significant issue. Currently the choices for maintaining fertility include in vitro
fertilization (IVF) and embryo cryopreservation, oocyte cryopreservation and the use of GnRH
agonist and antagonist to preserve ovarian function.
Much of the evidence for the use of GnRH agonist to prevent premature ovarian failure is
found in the systemic lupus erythematosus literature. Blumenfeld and colleagues have
published a report that demonstrates preservation of ovarian function in 100% of patients
treated with leuprolide acetate prior to cyclophosphamide therapy, compared to a 50% ovarian
failure rate in patients not receiving leuprolide acetate. Although the results of animal
studies and human studies are encouraging, adequately controlled trials are needed. Future
trials will need to have sufficient numbers of patients, receiving multiple types of
chemotherapeutic agents to adequately document the utility of medical prophylaxis. The
experience with ovulation induction suggests GnRH antagonists may have similar efficacy to
GnRH agonists. GnRH antagonists compete directly with GnRH in receptor binding, and as a
result antagonists rapidly inhibit secretion of gonadotropin and sex steroids. Unlike GnRH
agonists, GnRH antagonists have an immediate effect and antagonists can be given independent
of menstrual cycle day. These differences represent several practical benefits offered by an
antagonist. In a recent case series by Sauer et al, cetrorelix acetate, a GnRH antagonist,
was given in doses of 3mg at four day intervals to four patients ages 21-30. Menses was
preserved in all four patients and there was one spontaneous conception. Because of the
potential advantages of the use of a GnRH antagonist when compared to an agonist, cetrorelix
acetate will be studied against placebo in this investigation.
Our specific aim is to compare the rates of ovarian preservation in reproductive age women
receiving chemotherapeutic agents known to affect ovarian function who receive Cetrorelix
acetate co treatment with women who receive these agents and do not receive Cetrorelix
acetate. A second aim is to evaluate the ability of the Cetrorelix acetate co treatment to
induce therapeutic amenorrhea in a study population at risk for thrombocytopenia and
associated heavy vaginal bleeding.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02933190 -
Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy
|
N/A | |
| Withdrawn |
NCT00888082 -
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
|
Phase 3 |