Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders (POR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01926210
Recruitment Status : Unknown
Verified August 2013 by Huang Rui, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Huang Rui, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Infertility Other: mild stimulation protocol Other: controlled ovarian stimulation Phase 4

Detailed Description:

500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone (LH)level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.

The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: mild ovarian stimulation
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
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.
Other Names:
  • letrozole
  • recombinant FSH
  • GnRH antagonist

Active Comparator: controlled ovarian stimulation
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
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.
Other Names:
  • GnRH agonist
  • recombinant FSH




Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. live birth rate [ Time Frame: 10 months ]
  2. Number of oocytes retrieved [ Time Frame: 3 weeks ]
  3. Number of transferrable embryo [ Time Frame: 3 weeks ]
  4. normal fertilization rate [ Time Frame: 3 weeks ]
  5. implantation rate [ Time Frame: 7 weeks ]
  6. ongoing pregnancy rate [ Time Frame: 3 months ]
  7. Total dose of recombinant FSH consumption [ Time Frame: 3 weeks ]
  8. length of stimulation [ Time Frame: 3 weeks ]
  9. serum estradiol level [ Time Frame: 3 weeks ]
  10. serum LH level [ Time Frame: 3 weeks ]
  11. serum progesterone level [ Time Frame: 3 weeks ]
  12. serum FSH level [ Time Frame: 3 weeks ]
  13. FSH level in follicular fluid [ Time Frame: 3 weeks ]
  14. LH level in follicular fluid [ Time Frame: 3 weeks ]
  15. Estradiol level in the follicular fluid [ Time Frame: 3 weeks ]
  16. progesterone level in follicular fluid [ Time Frame: 3 weeks ]
  17. testerone level in the follicular fluid [ Time Frame: 3 weeks ]
  18. anti-müllerian hormone (AMH)level in follicular fluid [ Time Frame: 3 weeks ]
  19. Ovarian Hyperstimulation Syndrome (OHSS) rate [ Time Frame: 7 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926210


Contacts
Layout table for location contacts
Contact: Xing Yang, M.D. yxing8358@gmail.com

Locations
Layout table for location information
China, Guangdong
sixth affiliated hospital of Sun Yet-san University
Guangzhou, Guangdong, China, 510010
Contact: Yu Deng, M.D.       dengyu1983@yahoo.com.cn   
Principal Investigator: Rui Huang, M.D.         
Sponsors and Collaborators
Huang Rui
Investigators
Layout table for investigator information
Principal Investigator: Rui Huang, M.D. sixth affiliated hospital of Sun Yet-san University

Layout table for additonal information
Responsible Party: Huang Rui, M.D., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01926210    
Other Study ID Numbers: A-2013-01-05S
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013
Keywords provided by Huang Rui, Sun Yat-sen University:
Poor ovarian response
in vitro fertilization
mild ovarian stimulation
controlled ovarian stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs