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In Vitro Fertilization After Use of Chemotherapy
This study is currently recruiting participants.
Verified by New York Medical College, August 2007
First Received: August 22, 2007   Last Updated: February 3, 2009   History of Changes
Sponsor: New York Medical College
Information provided by: New York Medical College
ClinicalTrials.gov Identifier: NCT00520364
  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
Procedure: Controlled ovarian hyperstimulation, in vitro fertilization

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:


Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Response to controlled ovarian stimulation
  • AMH levels

Secondary Outcome Measures:
  • Ongoing pregnancy

Estimated Enrollment: 45
Study Start Date: June 2003
Estimated Study Completion Date: August 2007
Arms Assigned Interventions
A: Experimental
IVF after chemotherapy
Procedure: Controlled ovarian hyperstimulation, in vitro fertilization
B: Active Comparator
IVF without history of prior chemotherapy
Procedure: Controlled ovarian hyperstimulation, in vitro fertilization

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520364

Contacts
Contact: Kutluk Oktay, MD 2127464292 kuo9001@med.cornell.edu

Locations
United States, New York
Weill-Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Kutluk Oktay, MD     212-746-4292     kuo9001@med.cornell.edu    
Sponsors and Collaborators
New York Medical College
Investigators
Principal Investigator: Kutluk Oktay, MD Weill-Cornell Medical College
  More Information

No publications provided

Study ID Numbers: 0502007757
Study First Received: August 22, 2007
Last Updated: February 3, 2009
ClinicalTrials.gov Identifier: NCT00520364     History of Changes
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 08, 2010