NCT03457233

The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles

Status unknown NA Last updated 6 March 2018

What this trial tests

NA trial testing Gonadotropins in Invitro Fertilization in 185 participants. Status unknown.

Timeline

3 January 2015

Primary endpoint
1 March 2018

1 March 2018

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	185
Start date	3 January 2015
Primary completion	1 March 2018
Estimated completion	1 March 2018
Sites	1 location across Egypt

Drugs / interventions tested

• Gonadotropins — full drug profile →
• GNRH antagonist — full drug profile →
• Human chorionic gonadotropin Chorimon — full drug profile →
• Natural progesterone — full drug profile →

Conditions studied

• Invitro Fertilization — all drugs for Invitro Fertilization →

Sponsor

Cairo University

Who can join

Adults 20 to 44, female only, with Invitro Fertilization. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• clinical pregnancy rate
  Time frame: 4 weeks after HCG triggering
  appearance of intrauterine gestational sac by transvaginal ultrasound

Sponsor's own description

Induction of ovulation cycle:

1. Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
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.Serum E2 level is done on day of HCG trigger.
4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
5. Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
6. Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
7. 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).
8. The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of body mass index on the outcome of IVF cycles among patients with poor ovarian response.
   Maged AM, Fahmy RM, Rashwan H, Mahmood M, et al · · 2019 · cited 15× · PMID 30407618 · DOI 10.1002/ijgo.12706