Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle
1 other identifier
observational
100
1 country
1
Brief Summary
despite the large number of papers published on COH protocols comparing the efficiency of different exogenous gonadotropins, no confirmed protocol exists, and it is not quite clear which is superior to the others.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
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 31, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedSeptember 7, 2020
August 1, 2020
4 months
August 31, 2020
August 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients.
(pregnancy rate, abortion and live birth rate) in IVF patients.
5months
Study Arms (2)
group1
Group 1(50 case) which will receive hp FSH (fostimon ibsa) (150 IU per ampoule)will be started on day 2 of menstruation and then after six days, HMG (meriofert ibsa), 150 Iu, s.c) will be added
group2
Group 2(50 case) will be treated with recombinant FSH alone (Gonal-F) (150 IU per ampoule)
Interventions
Eligibility Criteria
Normal ovulatory function and normal semen analysis
You may qualify if:
- Aged 20-35 yr, male factor, 2-Tubal or unexplained infertility, 3-regular menstruation cycle between 21 and 35 days, 4-Normal function of uterus according to hysterosalpingography, hysteroscopy or transvaginal ultrasonography, 5-Normal ovaries according to transvaginal ultrasonography during past 6 months prior to study and compatible with normal adnexa and 6-Normal ovarian anatomy, and serum FSH level less than 8 IU/l All women showed no recognizable endometriosis according to symptoms and clinical examination in transvaginal ultrasonography or diagnostic laparoscopy. 7-7-All women have a history of unexplained infertility 8-Normal ovulatory function and normal semen analysis according to the World Health Organization criteria .
You may not qualify if:
- Patients with other ovulation disorders such as hypo and hypergonadotropic, hypogonadism, hyperprolactinemia.
- Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous history of systemic diseases such as endocrine and metabolic disorders.
- Previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders).
- Prior history of more than 3 unsucce
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
El neel
Minya, Egypt
Related Publications (1)
Kamel RM. The onset of human parturition. Arch Gynecol Obstet. 2010 Jun;281(6):975-82. doi: 10.1007/s00404-010-1365-9. Epub 2010 Feb 3.
PMID: 20127346BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 7, 2020
Study Start
September 1, 2020
Primary Completion
January 1, 2021
Study Completion
February 1, 2021
Last Updated
September 7, 2020
Record last verified: 2020-08