In Vitro Fertilization and Pregnancy After Use of Chemotherapy

Sponsor
New York Medical College (Other)
Overall Status
Terminated
CT.gov ID
NCT00520364
Collaborator
(none)
100
1
44.5
2.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Observation of IVF outcomes in relation to chemo history and AMH

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Actual Study Start Date :
Sep 15, 2014
Actual Primary Completion Date :
May 30, 2018
Actual Study Completion Date :
May 30, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Response to controlled ovarian stimulation [during IVF stimulation]

  2. AMH levels [during IVF]

Secondary Outcome Measures

  1. Ongoing pregnancy [after IVF]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IFP New York New York United States 10595

Sponsors and Collaborators

  • New York Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
kutluk oktay, PI, New York Medical College
ClinicalTrials.gov Identifier:
NCT00520364
Other Study ID Numbers:
  • 0502007757
First Posted:
Aug 24, 2007
Last Update Posted:
Aug 21, 2019
Last Verified:
Aug 1, 2019

Study Results

No Results Posted as of Aug 21, 2019