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Subcutaneous progesterone versus vaginal suppository for luteal phase support in assisted reproductive technology cycles in patients referred to Royan Institute

Subcutaneous progesterone (Prolutex) versus vaginal (Cyclogest) for luteal phase support in IVF/ICSI cycles: a randomized controlled clinical trial study phase 3

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201402191141N18
Enrollment
80
Registered
2015-02-19
Start date
2015-02-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Other complications associated with artificial fertilization. Complications associated with artificial fertilization

Interventions

Intervention 1: Intervention: Luteal phase support during ART treatment with subcutaneous injections of progesterone (Prolutex): since ovum pick up day, a daily subcutaneous injection of progeste
IBSA Institut, SA Biochimique) will be used and if pregnancy is occurred it continues until 10 weeks of pregnancy. Intervention 2: Control group : Luteal phase support during ART treatment using a v
Actavis, Barnstaple, UK), If pregnancy is occurred it continues until 10 weeks of pregnancy.
Treatment - Drugs
Intervention: Luteal phase support during ART treatment with subcutaneous injections of progesterone (Prolutex): since ovum pick up day, a daily subcutaneous injection of progesterone (25 mg) (P
IBSA Institut, SA Biochimique) will be used and if pregnancy is occurred it continues until 10 weeks of pregnancy.
Control group : Luteal phase support during ART treatment using a vaginal suppository (Cyclogest) : Since ovum pick up day, one vaginal suppository every 12 hours will be used (Cyclogest ®

Sponsors

Royan Institute
Lead Sponsor
Shafayab Gostar company
Collaborator

Eligibility

Sex/Gender
Female
Age
19 Years to 39 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Female age 19–39 years ; An written consent to participate in the study ;Body mass index (BMI ) <30 kg/m2 Exclusion Criteria: Severe male infertility (TESE, PESA) ; The uterine cause of infertility (uterine surgery history, cervical insufficiency, submucosal myoma or intramural fibroids = 5 cm and multiple uterine polyps) ; Patients with poor ovarian response or patients with reduced ovarian reserve (FSH = 15 IU/ml, AMH = 1 ng/ml) ; Tubal factor was diagnosed as hydrosalpinx ; Moderate and severe endometriosis (stage3and 4) ; Cases of repeated implantation failure (RIF) and spontaneous abortions.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate. Timepoint: Evidence of pregnancy by clinical (fetal heartbeat) or ultrasound parameters (ultrasound visualization of a gestational sac, embryonic pole with heartbeat)after 7-6 weeks after embryos transfer. Method of measurement: Vaginal sonography.;Pain during drug use. Timepoint: The patient records pain during drug using based on visual scale from 0 to 10. Method of measurement: Visual analog scale.;Comfort and satisfaction of drug. Timepoint: The patient records comfort and satisfaction during drug using based on visual scale from 0 to 10. Method of measurement: Visual analog scale.

Secondary

MeasureTime frame
Early Miscarriage rate. Timepoint: spontaneous loss of a pregnancy before 12 weeks. Method of measurement: Vaginal sonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ashraf Moini

Royan Institute

a_moini@royaninstitute.org+98 21 2356 2640

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026