In Vitro Fertilization and Pregnancy After Use of Chemotherapy

NCT ID: NCT00520364

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-15
• Study Completion Date: 2018-05-30

Brief 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).

Conditions

Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

History of chemotherapy

IVF after chemotherapy

Observation of IVF outcomes in relation to chemo history and AMH

Intervention Type: OTHER

Women undergoing IVF with or without history of chemotherapy, AMH levels compared

IVF without history of chemotherapy

IVF without history of prior chemotherapy

Observation of IVF outcomes in relation to chemo history and AMH

Intervention Type: OTHER

Women undergoing IVF with or without history of chemotherapy, AMH levels compared

Interventions

Observation of IVF outcomes in relation to chemo history and AMH

Women undergoing IVF with or without history of chemotherapy, AMH levels compared

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

New York Medical College

OTHER

Sponsor Role: lead

Responsible Party

kutluk oktay

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kutluk Oktay, MD

Role: PRINCIPAL_INVESTIGATOR

New York Medical College

Locations

IFP

New York, New York, United States

Countries

United States

Other Identifiers

0502007757

Identifier Type: -

Identifier Source: org_study_id