CClinicalTrials.gg
TerminatedNCT00520364Updated Aug 21, 2019

In Vitro Fertilization and Pregnancy After Use of Chemotherapy

An observational study in Cancer, sponsored by New York Medical College. Terminated at 1 site in United States. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by New York Medical College · Observational

Why this study was terminated
PI left the Institution.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 42 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

New York Medical College is the lead sponsor of 69 studies on the registry; 23 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Exclusion Criteria:

  • >42 years
  • Radiation below the diaphragm
  • Ovarian failure
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherObservation of IVF outcomes in relation to chemo history and AMH

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

06

What researchers measure

Primary outcomes

  1. Response to controlled ovarian stimulation

    Time frame: during IVF stimulation

  2. AMH levels

    Time frame: during IVF

Secondary outcomes

  1. Ongoing pregnancy

    Time frame: after IVF

07

Study locations

1 site
  • IFP
    New York, New York 10595, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00520364
Lead sponsor
New York Medical College
Responsible party
kutluk oktay (PI, New York Medical College) — Principal investigator
First posted
Aug 24, 2007
Start date
Sep 15, 2014
Primary completion
May 30, 2018
Completion
May 30, 2018
Last update
Aug 21, 2019

Study contacts

Kutluk Oktay, MD
principal investigator · New York Medical College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion