Ovarian Cancer Clinical Trial

In Vitro Fertilization and Pregnancy After Use of Chemotherapy

Summary

Objective: Chemotherapy regimens containing alkylating agents result in primordial follicle death and premature ovarian failure. Depending on the age and the type/dose of chemotherapy, some women may continue to menstruate. Our aim was to ascertain the impact of chemotherapy on ovarian reserve in patients who previously received chemotherapy by response to controlled ovarian hyper stimulation (COH) and anti-mullerian hormone (AMH) levels. Design: Prospective study with retrospective controls Materials and Methods: 45 cancer patients underwent controlled ovarian stimulation for IVF before (30 patients, 30 IVF cycles) or after (15 patients, 30 IVF cycles) chemotherapy. Patients with basal serum FSH >13mIU/mL or E2>70pg/ml were excluded. AMH was measured on previously stored serum samples from the day of initiation of the ovarian stimulation. Results: Mean ages and baseline FSH levels of pre- and postchemotherapy IVF patients were similar (36.8±0.91 vs. 36.3±1). The mean interval from completion of chemotherapy to IVF was 8.03±1.32 years (range 1-23). Of the 30 IVF cycles in post-chemotherapy patients, 22 received alkylating agents and 8 did not.

There were no significant differences between the study and control cycles regarding day-2 estradiol (E2), length of stimulation, total gonadotropin dose, and E2 on hCG day (table 2). Cycle cancellation rate was 20% and 26.67% for pre and post-chemotherapy patients, respectively. The number of oocytes retrieved and fertilized were significantly higher in pre-chemotherapy group (p<0.0001). Two clinical pregnancies were achieved in the postchemotherapy group, one ending in spontaneous abortion and the other in the delivery of a healthy baby (6.67% clinical pregnancy rate and 3.33% delivery rate per attempted cycle). All fertilized oocytes in the control group were cryopreserved at 2-pronuclei stage.

Baseline AMH levels were significantly lower in post chemotherapy IVF patients compared to those who underwent IVF prior to chemotherapy (0.270 ±0.077 vs. 0.84±0.27 ng/ml, p=0.03). In the pre-chemotherapy group there was a positive correlation between the AMH levels and the number of oocytes retrieved (r=0.663, p=0.004 ). This correlation was not detected in the post chemotherapy group (r=0.205).

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Eligibility Criteria

Inclusion Criteria:

Age 18-45 years
Histologically confirmed cancer diagnosis
Received chemotherapy more than one year ago
Have both ovaries
Regular menstrual cycle
Normal basal FSH, LH and estradiol

Exclusion Criteria:

>42 years
Radiation below the diaphragm
Ovarian failure

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

100

Study ID:

NCT00520364

Recruitment Status:

Terminated

Sponsor:

New York Medical College

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There is 1 Location for this study

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IFP
New York New York, 10595, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

100

Study ID:

NCT00520364

Recruitment Status:

Terminated

Sponsor:


New York Medical College

How clear is this clinincal trial information?

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