NCT01926210

Brief Summary

This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

August 14, 2013

Last Update Submit

August 20, 2013

Conditions

Infertility

Keywords

Poor ovarian responsein vitro fertilizationmild ovarian stimulationcontrolled ovarian stimulation

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    7 weeks

Secondary Outcomes (19)

  • live birth rate

    10 months

  • Number of oocytes retrieved

    3 weeks

  • Number of transferrable embryo

    3 weeks

  • normal fertilization rate

    3 weeks

  • implantation rate

    7 weeks

  • +14 more secondary outcomes

Study Arms (2)

mild ovarian stimulation

EXPERIMENTAL

Patients are stimulated with mild ovarian stimulation protocol,i.ed, from cycle day 3 to 7, letrozole 5mg per day are administrated and recombinant FSH 150 IU are given on day 4 and 6 . On cycle day 8, serum FSH LH, and estradiol levels are measured, and after then, the dose of recombinant FSH is adjusted according to the ovarian response and the maxim recombinant FSH dose is 150 IU/d. The GnRH-antagonist (Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum LH level rises above 2 times of basal LH level.

Other: mild stimulation protocol

controlled ovarian stimulation

ACTIVE COMPARATOR

Patients are stimulated using controlled ovarian stimulation protocol,i.e., from cycle day 18-22 (day 7 after ovulation) of previous cycle, all participants are given short-acting GnRH agonist (Triptorelin 0.05mg/d) for 14 days, then after checking serum FSH, LH and estradiol to make sure that complete downregulation is achieved, exogenous gonadotropin (recombinant FSH) 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.

Other: controlled ovarian stimulation

Interventions

mild stimulation protocolOTHER

letrozole is used from cycle day 3 to 7 and low dose recombinant FSH(no more than 150 IU/d) is used on cycle day 4,6 and 8 onwards. GnRH antagonist is only applied in case of premature LH rise might happen.

Also known as: letrozole, recombinant FSH, GnRH antagonist
mild ovarian stimulation
controlled ovarian stimulationOTHER

After fully downregulation by using short-acting GnRH agonist, 300 IU/d recombinant FSH is administrated for 5 days, then the dose is adjusted according to ovarian response.

Also known as: GnRH agonist, recombinant FSH
controlled ovarian stimulation

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)

You may not qualify if:

  • a. History of repeated IVF failure (previous IVF cycle \>2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sixth affiliated hospital of Sun Yet-san University

Guangzhou, Guangdong, 510010, China

Location

MeSH Terms

Conditions

Infertility

Interventions

LetrozoleLHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Rui Huang, M.D.

    sixth affiliated hospital of Sun Yet-san University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xing Yang, M.D.

CONTACT

yxing8358@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 20, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations

CN(1)