Poor Responders Infertile Patients -A Great Clinical Challenge

Status Completed

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Invitro Fertilization

Clinical Trial Details

NCT number	NCT03402620
Study type	Interventional
Source	Cairo University
Contact
Status	Completed
Phase	N/A
Start date	January 11, 2018
Completion date	June 4, 2018

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT02674178` - FSH/LH Ratio as a Predictor of IVF Outcome in Young and Older Women	Phase 4
Completed	`NCT01576991` - Telomeres and Reproduction in Women	N/A
Recruiting	`NCT03457233` - The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles	N/A
Completed	`NCT02660125` - Endometrial Injury and Implantation Rates Before First ICSI Cycle	N/A
Completed	`NCT03831542` - Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization
Not yet recruiting	`NCT03263299` - Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET With GnRH Agonist Flare-Up-Protocol	Phase 4
Completed	`NCT03118830` - Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI	Phase 4
Recruiting	`NCT02383394` - Factors Associated With Pregnancy Loss in IVF Women	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.