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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03484611
Enrollment
179
Registered
2018-04-02
Start date
2013-01-31
Completion date
2018-04-30
Last updated
2018-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invitro Fertilizaion

Brief 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.

Detailed description

A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Induction of ovulation cycle: 1. 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. 2. 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 3. 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. 4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection. 5. 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).

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

started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU

DRUGHuman chorionic gonadotropin

10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
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

Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like: 1. Severe male factor . 2. Uterine factor (eg: fibroid, polyp, Ashermann, .. etc) 3. Immunological disorder (eg: SLE, APS, … etc) 4. Thyroid or adrenal dysfunction 5. Neoplasia (especially: hypothalamic, pit, ovarian) 6. Women diagnosed with PCOS according to Rotterdam criteria 7. 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of the retrieved oocytes34 hours after HCG injectionnumber of oocytes retrieved 34 hours after HCG injection

Countries

Egypt

Contacts

Primary ContactAhmed Maged, MD
prof.ahmedmaged@gmail.com+2001005227404
Backup ContactRadwa Fahmy, MD
radwafahmi@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026