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Comparative Evaluation of the Efficacy, Safety and Tolerability of Oral Dydrogesterone and Micronised Vaginal Progesterone in Luteal Phase Support During Assisted Reproductive Treatment in Enugu South Eastern Nigeria.

Comparative Evaluation of the Efficacy, Safety and Tolerability of Oral Dydrogesterone and Micronised Vaginal Progesterone in Luteal Phase Support During Assisted Reproductive Treatment in Enugu South Eastern Nigeria.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202504881516590
Enrollment
112
Registered
2025-04-15
Start date
2025-04-14
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Fertility-female

Interventions

Group A
Group B

Sponsors

NWEZE SYLVESTER ONUEGBUNAM
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pre-menopausal women between 18 and 42 years of age. Body mass index [BMI] greater or equals to 18 but less than or equals to 30 kg/m2 with a documented history of infertility. Women were in their early follicular phase and follicle-stimulating hormone level was less than or equals to 15 IU/L and early follicular phase of estradiol which was less than 80 pg./ml. A normal transvaginal ultrasound at screening and a negative pregnancy test during pituitary down-regulation Women who underwent ART treatment in Fertility and Reproduction Centers. Participants who gave consent to this study. Participants who had no obvious co-morbidity that was contraindicated in luteal support.

Exclusion criteria

Exclusion criteria: Women with more than 3 unsuccessful ART attempts or history of more than or equals to 3 miscarriages Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ear, eye, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric disorders or other relevant diseases Women who had body mass index [BMI] less than 18 and greater than to 30 kg/m2 Women who had multiple gestation Women who were Allergic to progesterone (oral dydrogesterone [Duphaston] or micronised vaginal progesterone [Endometrin])

Design outcomes

Primary

MeasureTime frame
Effectiveness of oral dydrogesterone and micronised vaginal progesterone in luteal phase support during assisted reproductive treatment

Secondary

MeasureTime frame
the number of participants who despite adequate luteal phase support during assisted reproductive technology had uterine contraction, vaginal bleeding, additional interventions and miscarriages.

Countries

Nigeria

Contacts

Public ContactIfeanyichukwu Ofor

Lecturer 1

ofor.ifeanyi@gmail.com+2348037546411

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026