Status unknownNCT03484611Updated Apr 2, 2018

Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol

An interventional study of GnRH antagonist and Gonadotropins in Invitro Fertilizaion, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-04-02.

Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 179
Allocation: Non-randomized
Ages: 20 Years to 45 Years
Sex: Female

Study summary

A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.

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 to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.

Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.

Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization.

Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily.

Read the detailed description

A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles

Induction of ovulation cycle:

Gonadotrophines is started on day 2with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.
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 to induce final oocytes maturation , serum E2 is done on day of HCG trigger.
Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.
Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization. . Embryo transfer was performed under abdominal ultrasound guide for proper embryo placement to the mid-uterine cavity. 0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. The quality of the embryos were graded as 1,2,3 (1 being the best and 3 being the worst) based on the number of cells, degree of fragmentation and regularity. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK). Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily (IBSA, institut Biochemique,Switzerland).

Conditions studied

Invitro Fertilizaion

Who can participate

Ages eligible: 20 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

3- On antagonist protocol 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 NB: 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

Exclusion criteria

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. 8 . Untreated hyperprolactinemia 9 . Abnormal bleeding disorder

10.Hepatic or renal dysfunction 11.Hypersenstivity to study medication ( GNRH antagonist) 12.Need to take medication that can influence ovarian stimulation 13.Endometriosis grade 3 or 4 14.Ovarian cyst> 10 cm.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 179 participants (estimated)

Study arms

Active comparator
AMH < 0.3 ng/ml
Poor ovarian responders according to ESHRE consensus with serum AMH \< 0,3 ng/ml
Drug: GnRH antagonist · Drug: Gonadotropins · Drug: Human chorionic gonadotropin · Procedure: Embryo transfer · Drug: Progesterone
Active comparator
AMH 0.3 to 0.7 ng/ml
Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml
Drug: GnRH antagonist · Drug: Gonadotropins · Drug: Human chorionic gonadotropin · Procedure: Embryo transfer · Drug: Progesterone
Active comparator
AMH > 0.7 to 1 ng/ml
Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml
Drug: GnRH antagonist · Drug: Gonadotropins · Drug: Human chorionic gonadotropin · Procedure: Embryo transfer · Drug: Progesterone

Interventions

DrugGnRH antagonist
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
Also known as: cetrorelix
DrugGonadotropins
started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU
Also known as: Human menopausal gonadotropin
DrugHuman chorionic gonadotropin
10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more
Also known as: HCG
ProcedureEmbryo transfer
0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK)
DrugProgesterone
vaginal prontogest 400 mg twice daily

What researchers measure

Primary outcomes

Number of the retrieved oocytes
number of oocytes retrieved 34 hours after HCG injection
Time frame: 34 hours after HCG injection

Study locations

1 of 1 sites recruiting

Kasr Alainy medical school
Cairo, 12111, Egypt
- Ahmed Maged, MD · Contact · prof.ahmedmaged@gmail.com · 01005227404
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03484611
Lead sponsor: Cairo University
Responsible party: Ahmed Maged (professor, Cairo University) — Principal investigator
First posted: Apr 2, 2018
Start date: Jan 2013
Primary completion: Apr 2018 (estimated)
Completion: Apr 2018 (estimated)
Last update: Apr 2, 2018

Study contacts

Ahmed Maged, MD

Contact

prof.ahmedmaged@gmail.com

+2001005227404

Radwa Fahmy, MD

Contact

radwafahmi@yahoo.com

Ahmed Maged, MD

principal investigator · professor

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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