Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle

Ovarian Stimulation in ICSI Clinical Trial

Official title:

Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539613
• Other study ID #: COH in ICSI
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: August 2020
• Source: Minia University
• Contact: Amna Abdel sabour
• Phone: 01092405752
• Email: mannoon1991[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

, the objective of the current study was to compare the efficacy of 2 different ovarian stimulation protocols, comprising hpFSH, HMG versus R-FSH on oocyte and embryo quality and IVF treatment outcome in patients undergoing IVF or intracytoplasmic sperm injection (ICSI)(4).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: January 1, 2021
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• 1-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 .

Exclusion Criteria:

• Patients with other ovulation disorders such as hypo and hypergonadotropic, hypogonadism, hyperprolactinemia.

2-Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous history of systemic diseases such as endocrine and metabolic disorders.

6- Previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders).

7-Prior history of more than 3 unsucce

Related Conditions & MeSH terms

• Ovarian Stimulation in ICSI

Intervention

Drug:
• HPFSH & HMG
. Various gonadotropin preparations

Locations

Country	Name	City	State
Egypt	El neel	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Fouli Gaber Ebrahim

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients.	(pregnancy rate, abortion and live birth rate) in IVF patients.	5months