Controlled Ovarian Hyperstimulation (COH) With Sequential... | NCT04539613

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

NCT04539613

Sponsor

Alaa Fouli Gaber Ebrahim

Status

Unknown status

Last Update Posted

Sep 7, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Ovarian Stimulation in ICSI

Interventions

HPFSH & HMG

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Feb 1, 2021Estimated

First Submitted Date

Aug 31, 2020

First Submission Date that Met QC Criteria

Aug 31, 2020

First Posted Date

Sep 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Drug: HPFSH & HMG
group2		Group 2(50 case) will be treated with recombinant FSH alone (Gonal-F) (150 IU per ampoule)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HPFSH & HMG	Drug	. Various gonadotropin preparations	group1	rec-F.S.H

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients.	(pregnancy rate, abortion and live birth rate) in IVF patients.	5months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Normal ovulatory function and normal semen analysis

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Amna Abdel sabour	Contact	01092405752		mannoon1991@gmail.com
kareem shaheen	Contact	01003957442

Facility	Status	City	State	ZIP	Country	Contacts
El neel	Recruiting	Minya			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20127346	Background	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.