In Vitro Fertilization After Use of Chemotherapy
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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 |
- 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 ]
- Ongoing pregnancy [ Time Frame: after IVF ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | August 2012 |
| 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 |
Infertile women
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
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: | April 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 16, 2013