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Poor Responders Infertile Patients -A Great Clinical Challenge

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03402620
Collaborator
(none)
102
Enrollment
1
Location
2
Arms
4.7
Actual Duration (Months)
21.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Participants will be randomized to start induction with 4 or 6 ampoules of gonadotropins from day 2 till the day of human chorionic gonadotropin (HCG), dose adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by TVUS scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day 6 for folliculometry and endometrial thickness and pattern. Cetrotide (MerckSerono, Germany) 0.25 subcutaneously will be added when the leading follicle (DF) reaches >12 mm and HCG 10 000 IU intramuscularly (Pregnyl, Merck Sharp, United Kingdom)will be given only if we have at least 3 mature follicles >14 mm and the leading one >17 mm; then, ovum pickup (OPU) was done after 36 hours of HCG and metaphase II ocytes were analyzed. The intracytoplasmic sperm injection (ICSI) procedure will be performed in all cases to avoid low fertilization rate by conventional IVF. Fertilization was assessed 16 to 18 hours after ICSI, and embryo quality will be evaluated 2 and 3 days after ICSI according to the number of blastomeres and the degree of fragmentation and multinucleation. Oocytes were collected and embryos will be cultured in ISM1 culture medium (Origiomedicult media, Denmark). Transfer of cleaving embryos will be done on day 3 after oocyte retrieval (using Labotect semirigid catheter; labotect GmbH, Germany), when the woman has at least 1 embryo (GI) otherwise canceled embryo transfer (ET). The ET was done by 1 person in each center. Both of the transferring consultants have more than 5 years experience in IVF unit. . All patients will receive luteal support in the form of daily progesterone cyclogest (Actavis, United Kingdom) 800 mg daily starting from day of ovum retrieval till day of hCG testing. Serum b hCG level was assessed on day 14 after ET and considered positive if >5 mIU/ml. The TVUS was performed 28 days after ET to confirm ongoing pregnancy by visualization of intrauterine sac.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Starting Dose of Gonadotropin for Poor Responders in IVF Cycles
Actual Study Start Date :
Jan 11, 2018
Actual Primary Completion Date :
Jun 4, 2018
Actual Study Completion Date :
Jun 4, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: four ampoules group

gonadotropin starting dose is 4 ampoules daily

Drug: Gonadotropins
Human menopausal gonadotropin 75 IU ampoules start at cycle day 2
Active Comparator: six ampoules group

gonadotropin starting dose is 6 ampoules daily

Drug: Gonadotropins
Human menopausal gonadotropin 75 IU ampoules start at cycle day 2

Outcome Measures

Primary Outcome Measures

  1. number of retrieved oocytes [34 hours after HCG triggering]

    The number of oocyte retrived at ovum pickup

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 44 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Poor responders according to "Bologna consensus" with at least 2 of the following 3 points should be present:

  1. Age >40 years or other cause of poor function.

  2. AFC<2-5 in both ovaries or AMH < 0.5-1.1 ng/dl 2)

  3. History of poor response with conventional stimulation protocol

Exclusion Criteria:

  1. Uterine factor.

  2. Severe male factor.

  3. Endometriosis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Alainy medical school Cairo Egypt 12111

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Ahmed Maged, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier:
NCT03402620
Other Study ID Numbers:
  • 20
First Posted:
Jan 18, 2018
Last Update Posted:
Jun 6, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jun 6, 2018