Clinical trial NCT00520364: In Vitro Fertilization and Pregnancy After Use of Chemotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2007-08-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile women

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).


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

Primary outcomes:
measure: Response to controlled ovarian stimulation
timeFrame: during IVF stimulation
measure: AMH levels
timeFrame: during IVF
Secondary outcomes:
measure: Ongoing pregnancy
timeFrame: after IVF
Other outcomes:
Locations:
city: New York
country: United States
facility: IFP
state: New York
Study officials:
affiliation: New York Medical College
name: Kutluk Oktay, MD
role: PRINCIPAL_INVESTIGATOR
References: