NCT02288143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

November 6, 2014

Last Update Submit

December 1, 2015

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    12 days

Secondary Outcomes (2)

  • Number of embryos

    17 days

  • Ovarian hyper-stimulation syndrome

    1 month

Study Arms (1)

COOL-COS

EXPERIMENTAL

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

Drug: COOL-COS

Interventions

COOL-COSDRUG

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.

Also known as: Friendly COS
COOL-COS

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Setor de Reproducao Humana do HC-FMRP-USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 23250342RESULT

  • 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.

    PMID: 24348019RESULT

  • 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;2013(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.

    PMID: 23543584RESULT

  • 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.

    PMID: 24182414RESULT

  • 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.

    PMID: 25302750RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 11, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

BR(1)