Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

In Vitro Fertilization and Pregnancy After Use of Chemotherapy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
kutluk oktay, New York Medical College
ClinicalTrials.gov Identifier:
NCT00520364
First received: August 22, 2007
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 Intervention
Cancer
Other: Observation of IVF outcomes in relation to chemo history and AMH

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Response to controlled ovarian stimulation [ Time Frame: during IVF stimulation ] [ Designated as safety issue: No ]
  • AMH levels [ Time Frame: during IVF ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ongoing pregnancy [ Time Frame: after IVF ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 100
Study Start Date: September 2014
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infertile women

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520364

Locations
United States, New York
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
  More Information

No publications provided

Responsible Party: kutluk oktay, PI, New York Medical College
ClinicalTrials.gov Identifier: NCT00520364     History of Changes
Other Study ID Numbers: 0502007757
Study First Received: August 22, 2007
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014