In Vitro Fertilization and Pregnancy After Use of Chemotherapy

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).

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Other: Observation of IVF outcomes in relation to chemo history and AMH

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10595
      • IFP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Infertile women

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
History of chemotherapy; IVF after chemotherapy	Other: Observation of IVF outcomes in relation to chemo history and AMH; Women undergoing IVF with or without history of chemotherapy, AMH levels compared
IVF without history of chemotherapy; IVF without history of prior chemotherapy	Other: Observation of IVF outcomes in relation to chemo history and AMH; Women undergoing IVF with or without history of chemotherapy, AMH levels compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response to controlled ovarian stimulation	during IVF stimulation
AMH levels	during IVF

Secondary Outcome Measures

Outcome Measure	Time Frame
Ongoing pregnancy	after IVF

Collaborators and Investigators

• Sponsor: New York Medical College
• Investigators: Principal Investigator: Kutluk Oktay, MD, New York Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2014
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: August 22, 2007
• First Submitted That Met QC Criteria: August 23, 2007
• First Posted (Estimate): August 24, 2007

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 0502007757