J Clin Gynecol Obstet

Journal of Clinical Gynecology and Obstetrics, ISSN 1927-1271 print, 1927-128X online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Gynecol Obstet and Elmer Press Inc

Journal website https://jcgo.elmerpub.com

Review

Volume 000, Number 000, January 2026, pages 000-000

Reflections on the Challenges of Infertility-Based Randomized Controlled Trials

**Table 1.** Responsibility Related to Trial Associated Activities in Pharma-Sponsored, Investigator-Initiated Trials and Our Own RCT
	Pharma-sponsored	Investigator-initiated	Our own RCT
IRB: Institutional Review Board; RCT: randomized controlled trial.
Hypothesis generation	By sponsor	By investigator	By chief investigator
Preparation of the protocol	By sponsor	By investigator	By chief investigator
Recruitment of co-investigators: feasibility questionnaire	By sponsor/monitoring company	By investigator in person/online discussion	Pre-study online discussion
Determining the interventions/arms	By sponsor	By investigator	By chief investigator
Setting up the inclusion-exclusion criteria	By sponsor	By investigator	By chief investigator
Determining the 1° and 2° outcomes	By sponsor	By investigator	By chief investigator
Sample size calculation	By sponsor	By investigator	By chief investigator
Randomization	By sponsor; central list, proper concealment	By investigator; central list, concealment may be an issue	Randomization list prepared by statistician, central access, concealment problematic
Blinding	Arranged by sponsor if blinding is needed/possible	Often problematic	Providers/patients not blinded to treatment
Placebo group	If required, arranged by sponsor	Rarely used; Who prepares the placebo? Who pays for it?	There was no placebo group
Statistical methods	By sponsor	By investigator/statistician	By statistician
Single-center vs. multi-center RCT	Almost always multi-center	Mostly single center	Multicenter
IRB approval	Monitoring company	By investigator	By chief investigator
Local ethical procedures	Monitoring company	By investigator	By chief investigator
Insurance	By investigator	By investigator or no extra insurance	Additional insurance was mandated by regulatory authorities
Trial registration	By sponsor	By investigator	By chief investigator in ClinicalTrials
Funding	By sponsor	None or through funds	None
Data collection	By sponsor and monitoring company	By investigator(s)	Chief and local investigators
Patient enrollment/maintenance	Local investigators	By investigator(s)	Local investigators
Periodic follow-up	By sponsor and monitoring company	By chief investigator or none	Only ad hoc follow-up, no regular follow-up
Statistical analysis	By sponsor	By investigator/statistician	By chief investigators
Publication - publication expenses	By sponsor	By investigator	By investigator, no funding, open access publication not an option

Table 1. Responsibility Related to Trial Associated Activities in Pharma-Sponsored, Investigator-Initiated Trials and Our Own RCT

Pharma-sponsored

Investigator-initiated

Our own RCT

IRB: Institutional Review Board; RCT: randomized controlled trial.

Hypothesis generation

By sponsor

By investigator

By chief investigator

Preparation of the protocol

By sponsor

By investigator

By chief investigator

Recruitment of co-investigators: feasibility questionnaire

By sponsor/monitoring company

By investigator in person/online discussion

Pre-study online discussion

Determining the interventions/arms

By sponsor

By investigator

By chief investigator

Setting up the inclusion-exclusion criteria

By sponsor

By investigator

By chief investigator

Determining the 1° and 2° outcomes

By sponsor

By investigator

By chief investigator

Sample size calculation

By sponsor

By investigator

By chief investigator

Randomization

By sponsor; central list, proper concealment

By investigator; central list, concealment may be an issue

Randomization list prepared by statistician, central access, concealment problematic

Blinding

Arranged by sponsor if blinding is needed/possible

Often problematic

Providers/patients not blinded to treatment

Placebo group

If required, arranged by sponsor

Rarely used; Who prepares the placebo? Who pays for it?

There was no placebo group

Statistical methods

By sponsor

By investigator/statistician

By statistician

Single-center vs. multi-center RCT

Almost always multi-center

Mostly single center

Multicenter

IRB approval

Monitoring company

By investigator

By chief investigator

Local ethical procedures

Monitoring company

By investigator

By chief investigator

Insurance

By investigator

By investigator or no extra insurance

Additional insurance was mandated by regulatory authorities

Trial registration

By sponsor

By investigator

By chief investigator in ClinicalTrials

Funding

By sponsor

None or through funds

None

Data collection

By sponsor and monitoring company

By investigator(s)

Chief and local investigators

Patient enrollment/maintenance

Local investigators

By investigator(s)

Local investigators

Periodic follow-up

By sponsor and monitoring company

By chief investigator or none

Only ad hoc follow-up, no regular follow-up

Statistical analysis

By sponsor

By investigator/statistician

By chief investigators

Publication - publication expenses

By sponsor

By investigator

By investigator, no funding, open access publication not an option