RCT of Low-dose Clomiphene vs. High Dose Gonadotropin Protocol for IVF Poor Responders

Infertility Clinical Trial

— CLOVANT  

Official title:

Randomized Prospective Controlled Non-inferiority Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01577199
• Other study ID #: 1112012095
• Status: Withdrawn
• Phase: Phase 4
• First received: April 11, 2012
• Last updated: December 15, 2016
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.

Description:

The objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 IU) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol.

Patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the LH surge, with high dose gonadotropins (600IU) alone, starting on day 2 of the cycle. After randomization, patients will undergo routine IVF procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Patients age 18-42 undergoing IVF

• AFC <7 (see definition above) and AMH (see definition above) <0.5 and/or prior poor IVF response

Exclusion Criteria:

• BMI (body mass index) >30

• PGD (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities)

• Age >42

• Fragile X carriers (a condition associated with premature ovarian aging)

• TESE (Testicular sperm extraction)

• Asherman's syndrome (uterine scarring which can affect implantation and pregnancy)

• Untreated hydrosalpinx (accumulated fluid in the fallopian tube which may be toxic to embryos)

• >6 prior attempted cycles

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Low-dose Clomiphene
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed by clomiphene citrate 100mgon days 2-6 of the menstrual cycle with 225 international units of gonadotropins (eg Follistim , Menopur) starting on day 5
• High dose gonadotropins
Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed high dose gonadotropins (eg. Follistim. Menopur) 600IU starting on day 2 of the cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of mature oocytes retrieved	To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders	1 year	No
Secondary	The number of embryos transferred	To evaluate the number of embryos transferred	1year	No

External Links

•   Center for Reproductive Medicine