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COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
COOL-COS
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women scheduled to controlled ovarian stimulation for oocyte retrieval.
  • Body mass index: 18-35 Kg/m2.
  • Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle >10mm and serum estradiol ≥ 40 pg/L).
  • Signing an informed consent.

Exclusion Criteria:

  • No exclusion criteria.

Sites / Locations

  • Setor de Reproducao Humana do HC-FMRP-USP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COOL-COS

Arm Description

All women will receive the intervention: Letrozole, Clomiphene, and low-dose hMG for the controlled ovarian stimulation.

Outcomes

Primary Outcome Measures

Number of oocytes retrieved

Secondary Outcome Measures

Number of embryos
Ovarian hyper-stimulation syndrome

Full Information

First Posted
November 6, 2014
Last Updated
December 1, 2015
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02288143
Brief Title
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation
Acronym
COOL-COS
Official Title
Evaluation of a Simplified Low-cost and Friendly Controlled Ovarian Stimulation Combining Oral Letrozole and Clomiphene Citrate: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of oocytes retrieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COOL-COS
Arm Type
Experimental
Arm Description
All women will receive the intervention: Letrozole, Clomiphene, and low-dose hMG for the controlled ovarian stimulation.
Intervention Type
Drug
Intervention Name(s)
COOL-COS
Other Intervention Name(s)
Friendly COS
Intervention Description
Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation. hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation. The triggering will be performed using urinary hCG (5,000 IU subcutaneous). 1-2 days after the identification of one follicle ≥ 17 mm 0-1 days after the identification of one follicle ≥ 19 mm.
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Number of embryos
Time Frame
17 days
Title
Ovarian hyper-stimulation syndrome
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women scheduled to controlled ovarian stimulation for oocyte retrieval. Body mass index: 18-35 Kg/m2. Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle >10mm and serum estradiol ≥ 40 pg/L). Signing an informed consent. Exclusion Criteria: No exclusion criteria.
Facility Information:
Facility Name
Setor de Reproducao Humana do HC-FMRP-USP
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23250342
Citation
Figueiredo JB, Nastri CO, Vieira AD, Martins WP. Clomiphene combined with gonadotropins and GnRH antagonist versus conventional controlled ovarian hyperstimulation without clomiphene in women undergoing assisted reproductive techniques: systematic review and meta-analysis. Arch Gynecol Obstet. 2013 Apr;287(4):779-90. doi: 10.1007/s00404-012-2672-0. Epub 2012 Dec 19.
Results Reference
result
PubMed Identifier
24348019
Citation
Hajishafiha M, Dehghan M, Kiarang N, Sadegh-Asadi N, Shayegh SN, Ghasemi-Rad M. Combined letrozole and clomiphene versus letrozole and clomiphene alone in infertile patients with polycystic ovary syndrome. Drug Des Devel Ther. 2013 Dec 3;7:1427-31. doi: 10.2147/DDDT.S50972. eCollection 2013. Erratum In: Drug Des Devel Ther. 2017 Apr 28;11:1367.
Results Reference
result
PubMed Identifier
23543584
Citation
Martins WP, Vieira AD, Figueiredo JB, Nastri CO. FSH replaced by low-dose hCG in the late follicular phase versus continued FSH for assisted reproductive techniques. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.
Results Reference
result
PubMed Identifier
24182414
Citation
Seko LM, Moroni RM, Leitao VM, Teixeira DM, Nastri CO, Martins WP. Melatonin supplementation during controlled ovarian stimulation for women undergoing assisted reproductive technology: systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2014 Jan;101(1):154-161.e4. doi: 10.1016/j.fertnstert.2013.09.036. Epub 2013 Oct 29.
Results Reference
result
PubMed Identifier
25302750
Citation
Nastri CO, Teixeira DM, Moroni RM, Leitao VM, Martins WP. Ovarian hyperstimulation syndrome: pathophysiology, staging, prediction and prevention. Ultrasound Obstet Gynecol. 2015 Apr;45(4):377-93. doi: 10.1002/uog.14684. Epub 2015 Mar 1.
Results Reference
result

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COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation

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