Dienogest versus Leuprolide prior to in-vitro-fertilization (IVF) cycle in women with endometriosis associated infertility

Dienogest versus GnRH-agonist (Leuprolide) prior to in-vitro-fertilization (IVF) cycle in women with endometriosis associated infertility: a randomized controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020185

Enrollment

Registered

2019-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Dienogest: Group 1 will be given tab Dienogest 2 mg daily once a day for 28 days before IVF Control Intervention1: GnRH agonist(leuprolide): Group 2 will be given inj.Leuprolide 3.75 mg

Eligibility

Inclusion criteria

Inclusion criteria: 1)Endometriosis planned for IVF 2)Diagnosed endometriosis at laparoscopy and or USG 3)FSH = 1.5 ng/ml 4)Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1)Recurrent endometrioma 2)Prior surgery on ovary including endometrioma drainage /cystectomy 3)BMI > 30 kg/m2 4)Uterine factor unfavorable for implantation (adenomyosis, intrauterine adhesions, thin endometrium, submucous fibroids)

Design outcomes

Primary

Measure	Time frame
Clinical pregnancy rate Timepoint: 4 months from date of 1st recruitment	—

Secondary

Measure	Time frame
1) Response to COS a) Total dose of gonadotropins b) Number of days of stimulation c) Total number of oocytes retrieved d) Number of metaphase II oocytes e) Total number of embryos f) Fertilization rate g) Cleavage rate h) Number of grade 1 embryos i) OHSS rate 2) Implantation rate 3) Miscarriage rate 4) Ectopic pregnancy rate 5) Live Birth Rate Timepoint: 2 yrs 6 months from date of first recruitment	—

Measure

Time frame

1) Response to COS a) Total dose of gonadotropins b) Number of days of stimulation c) Total number of oocytes retrieved d) Number of metaphase II oocytes e) Total number of embryos f) Fertilization rate g) Cleavage rate h) Number of grade 1 embryos i) OHSS rate 2) Implantation rate 3) Miscarriage rate 4) Ectopic pregnancy rate 5) Live Birth Rate Timepoint: 2 yrs 6 months from date of first recruitment

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Countries

India

Contacts

Public ContactDr Anshu Yadav

AIIMS, New Delhi

anshugunwal@gmail.com9821538756

Outcome results