In Vitro Fertilization and Pregnancy After Use of Chemotherapy

NCT00520364 | Terminated

• 1 other identifier: 0502007757
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Response to controlled ovarian stimulation

  during IVF stimulation

• AMH levels

  during IVF

Secondary Outcomes (1)

• Ongoing pregnancy

  after IVF

Study Arms (2)

History of chemotherapy

IVF after chemotherapy

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

IVF without history of chemotherapy

IVF without history of prior chemotherapy

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

Interventions

Observation of IVF outcomes in relation to chemo history and AMH OTHER

Women undergoing IVF with or without history of chemotherapy, AMH levels compared

History of chemotherapy; IVF without history of chemotherapy

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile women

You may qualify if:

• 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

You may not qualify if:

• \>42 years
• Radiation below the diaphragm
• Ovarian failure

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

IFP

New York, New York, 10595, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Neoplasms

Interventions

Anti-Mullerian Hormone

Intervention Hierarchy (Ancestors)

Testicular Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Kutluk Oktay, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 24, 2007
• Study Start: September 15, 2014
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

US (1)