The Impact of Body Weight on Reproductive Outcomes in Poo... | NCT03457233

Studies
The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles

NCT03457233

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 7, 2018Actual

Enrollment

185Estimated

Phase

Not Applicable

Conditions

Invitro Fertilization

Interventions

Gonadotropins
GNRH antagonist
Human chorionic gonadotropin Chorimon
Natural progesterone

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

Mar 2018

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

Jan 3, 2015Actual

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Feb 25, 2018

First Submission Date that Met QC Criteria

Mar 6, 2018

First Posted Date

Mar 7, 2018Actual

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

Mar 6, 2018

Last Update Posted Date

Mar 7, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Induction of ovulation cycle:

Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5)to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given.Serum E2 level is done on day of HCG trigger.
Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100

Detailed Description

Induction of ovulation cycle:

Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5)to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given.Serum E2 level is done on day of HCG trigger.
Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

185Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal weight	Active Comparator	18.5- 24.9 kg/m2	Drug: Gonadotropins Drug: GNRH antagonist Drug: Human chorionic gonadotropin Chorimon Drug: Natural progesterone
Overweight	Active Comparator	BMI 25-29.9 kg/m2	Drug: Gonadotropins Drug: GNRH antagonist Drug: Human chorionic gonadotropin Chorimon Drug: Natural progesterone
Obese	Active Comparator	BMI ≥ 30 kg/m2	Drug: Gonadotropins Drug: GNRH antagonist Drug: Human chorionic gonadotropin Chorimon Drug: Natural progesterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gonadotropins	Drug	1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration	Normal weight Obese Overweight

Measure	Description	Time Frame
clinical pregnancy rate	appearance of intrauterine gestational sac by transvaginal ultrasound	4 weeks after HCG triggering

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present: Advanced maternal age (≥ 40 years old) or any other risk factor A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol)An abnormal ovarian reserve test (ORT); antral follicle count (AFC) < 5-7 follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus.

Presence and Adequate visualization of both ovaries Uterine cavity within normal anatomy assessed with HSG, hysteroscopy and TVUS

Exclusion Criteria:

Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:

Severe male factor .
Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
Immunological disorder (eg: SLE, APS, … etc)
Thyroid or adrenal dysfunction
Neoplasia (especially: hypothalamic, pit, ovarian)
Women diagnosed with PCOS according to Rotterdam criteria
Hydrosalpinx that hasn't been surgically removed or ligated.
Untreated hyperprolactinemia
Abnormal bleeding disorder
Hepatic or renal dysfunction
Hypersenstivity to study medication ( GNRH antagonist)
Need to take medication that can influence ovarian stimulation
Endometriosis grade 3 or 4
Ovarian cyst> 10 cm.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ahmed Maged, MD	Contact	+2001005227404		prof.ahmedmaged@gmail.com
Radwa Fahmy, MD	Contact			radwafahmi@yahoo.com

Name	Affiliation	Role
Ahmed Maged	professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school	Recruiting	Cairo		12111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30407618	Derived	Maged AM, Fahmy RM, Rashwan H, Mahmood M, Hassan SM, Nabil H, Hany A, Lotfy R, Lasheen YS, Dahab S, Darwish M. Effect of body mass index on the outcome of IVF cycles among patients with poor ovarian response. Int J Gynaecol Obstet. 2019 Feb;144(2):161-166. doi: 10.1002/ijgo.12706. Epub 2018 Nov 26.

ID	Term
D006062	Gonadotropins
D008596	Menotropins
C092464	LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-
C062876	cetrorelix

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D006065	Gonadotropins, Pituitary